FDA Approves Once-Monthly Injection For Hereditary Angioedema; What It Means For Long-Term Treatment?

Updated Jun 23, 2025 | 05:00 AM IST

SummaryThe newly approved Andembry, a once-monthly self-injection for hereditary angioedema, offering over 99% attack reduction and long-term relief for patients aged 12 and older with this rare genetic condition.
FDA Approves Once-Monthly Injection For Hereditary Angioedema; What It Means For Long-Term Treatment?

As a significant breakthrough in rare disease therapy, the U.S. Food and Drug Administration (FDA) has just approved Andembry (garadacimab‑gxii), the first-ever prophylactic treatment that aims for factor XIIa to prevent attacks of hereditary angioedema (HAE). This once-monthly injectable has provided patients 12 years and older with a new, convenient way to manage symptoms effectively—but its significance extends far beyond convenience, as it is a sea change in the way we treat this incapacitating illness.

Hereditary angioedema is an inherited, rare illness that results in sudden, aching swelling of the body's different regions, such as the face, limbs, or inner tissues like the airway or intestines. Blockages caused by it can result in life-threatening respiratory problems or severe abdominal pain. These occur because leakage from small blood vessels lets fluid seep into nearby tissues. HAE typically presents in childhood or adolescence, worsens after puberty, and strikes almost everyone diagnosed through age 20.

While the swelling may be painful and disfiguring, the most significant danger is airway involvement, which can be fatal. Conventional treatments are primarily concerned with treating these sudden attacks or maintaining regular infusions to prevent them. But until now, real long-term prevention was out of reach.

How Andembry Works?

Andembry is a monoclonal antibody that directly blocks factor XIIa, a central protein in the cascade of processes that leads to HAE attacks. By blocking factor XIIa's action, Andembry stops the process before swelling occurs—making the first line of defense against unpredictable flare-ups.

Administered through a straightforward autoinjector that delivers the dose in 15 seconds or less, Andembry is designed to become an integral part of patients' lives. Users simply have to self-administer the injection on a monthly basis, making it a convenient option for teenagers as well as adults who are treating this condition.

The FDA's approval is based on powerful Phase III clinical trial data. During six months, 62% of Andembry patients were wholly attack-free—a remarkable benchmark for a disease characterized by constant flare-ups.

Are There Any Possible Side Effects?

Like any drug, Andembry has potential side effects, although most were mild. The most frequent problems encountered involved nasal and upper throat inflammation and abdominal pain, each of which were observed in approximately 7% of patients. Most importantly, no severe adverse events or drop-outs from treatment were seen—testifying to the drug's overall safety and tolerability.

Such a positive profile represents an important victory for a long-term treatment—particularly one that will be repeatedly self-administered by families and patients.

Dr. Bill Mezzanotte, R&D Head at CSL (who created Andembry), refers to the drug as a "game-changer". He mentions it's the first monoclonal antibody to be created wholly by CSL and the only injectable treatment for factor XIIa. The fact that it's designed to give treatment in seconds speaks to a patient-centric focus—particularly necessary for a disease that is notoriously unpredictable and can hit at any time.

What This Means for HAE Treatment and Care

Apart from clinical efficacy, Andembry vows to greatly improve the daily lives of HAE patients. The benefits in everyday life are:

  • Relief from emotional distress of never knowing when the swelling will occur
  • Fewer visits to emergency rooms and reliance on on-demand drugs
  • More independence to travel, socialize, and enjoy activities
  • Better school or work productivity because of more consistent health

Preventing attacks before they occur can cut down school or workplace absences, decrease hospital visits, and reduce emergency care expenses—all substantial quality-of-life differences.

Andembry's approval represents a tipping point in the direction of personalized, preventive treatment for HAE. It changes the emphasis from responding to swelling attacks to actively preventing them, a shift with broad implications for patients and the health care system as a whole.

Providers now have a powerful, easy-to-use option to present to patients and families. Investigators are looking at whether Andembry can supplant or minimize the use of current prophylactics, like C1 inhibitor treatments or bradykinin receptor antagonists.

Economically, although monoclonal antibody therapies are generally very expensive, Andembry's ability to decrease emergency room visits and hospital stays could potentially yield dramatic cost savings for both patients and payers over time.

With Andembry's approval, individuals with hereditary angioedema can now receive a once-per-month injection that provides near-total attack prevention, outstanding safety, and improved quality of life. For the increasingly large population of diagnosed and undiagnosed patients, Andembry provides a new level of confidence and control in managing a condition long known to be capricious and highly restrictive.

End of Article

RFK Jr. Claims CDC’s Latest Vaccine–Autism Guidance Was Issued Under His Direction

Updated Nov 23, 2025 | 12:00 PM IST

SummaryRFK Jr.’s decision to push the CDC toward new vaccine–autism language has alarmed medical experts, who say the update conflicts with long-established scientific evidence. Keep reading for more details.
cdc autism claims

Credits: Public Forum

Health Secretary Robert F. Kennedy Jr. told The New York Times that he personally instructed the U.S. Centers for Disease Control and Prevention to revise its long-standing message that vaccines do not cause autism. His disclosure, published Friday, confirms who was behind the surprising shift that caught many current and former CDC employees off guard earlier in the week.

Kennedy, who has a long history of opposing routine vaccination, has increasingly unsettled the public health agencies he now leads. His recent moves have raised concerns across the medical community, which sees many of his decisions as placing Americans at risk.

CDC Website Autism Vaccine Claim: What Kennedy Said and What Changed

In the interview, Kennedy dismissed the CDC’s previous guidance, calling the agency’s long-held position on vaccine safety “a lie.” The CDC’s updated “vaccine safety” page now argues that the statement “vaccines do not cause autism” cannot be proven with absolute certainty and implies that officials have disregarded research that hints at a possible link, as per CNN.

This new language conflicts with decades of scientific evidence and goes against the consensus view shared by independent researchers, pediatric groups and global health authorities.

How the Scientific Community Responded

Public health experts reacted sharply, warning that the revisions distort how evidence is evaluated in science. Researchers emphasized that while science cannot prove a negative, extensive data can rule out likely causes, and that is what has happened in the case of vaccines and autism, as per CNN.

Autism advocacy groups called the claim misleading. The Autism Science Foundation repeated that vaccines remain one of the most thoroughly investigated environmental factors linked to autism and that research across many countries and large populations has consistently found no association.

What the Science Actually Shows About Vaccines and Autism

Scientists have studied vaccines and autism for more than two decades. Large population studies in the United States, Europe and Asia have looked at the measles, mumps and rubella (MMR) vaccine, thimerosal-containing vaccines, and the timing of childhood immunization. Each line of research has reached the same conclusion: vaccines do not cause autism.

These findings have come from independent academic teams, government-funded studies and international health agencies, using different methods, age groups and datasets. Experts say the updated CDC wording misrepresents this evidence and may create unwarranted fear among parents, as per CNN.

A Promise Broken

Kennedy had previously assured Sen. Bill Cassidy, who chairs the Senate health committee, that he would keep the statement “vaccines do not cause autism” on the CDC website during his confirmation process. While the line remains, it now appears with a disclaimer noting that it was kept there specifically because of their agreement.

Cassidy said he opposed the update after Kennedy informed him of the change. The senator later warned that parents need clear reassurance, not confusion, especially on diseases like measles, polio and hepatitis B, where vaccination is proven to prevent severe illness.

A Wider Pattern of Disruption

The CDC website change is only one part of a broader shift under Kennedy’s leadership. He has withdrawn half a billion dollars from vaccine development initiatives, removed every member of a federal vaccine advisory panel, and signaled plans to overhaul the national vaccine injury compensation program.

He also dismissed former CDC Director Susan Monarez within weeks of her appointment after policy disagreements.

RFK Jr. Claims About The Vaccine Has Growing Distrust Within Medicine

Leaders in pediatrics and infectious disease warned Thursday that the new website language fuels misinformation rather than clarifying public health advice. Dr. Sean O’Leary of the American Academy of Pediatrics called the change “madness” and said it undermines confidence in the nation’s most basic health protections.

The Department of Health and Human Services did not respond to requests for comment.

End of Article

Living In Delhi's Toxic Air Is A 'Medical Emergency', According AIIMS Doctors

Updated Nov 22, 2025 | 12:22 PM IST

SummaryDelhi’s AQI hit 315 on November 22, with pollution levels still hazardous—equivalent to smoking 10.8 cigarettes a day. AIIMS doctors warn the situation is a medical emergency, posing generational risks, especially to pregnant women and infants. Experts advise N-95 masks, avoiding morning walks, wet mopping, vitamin C, hydration, and air purifiers.
Living In Delhi's Toxic Air Is A 'Medical Emergency', According AIIMS Doctors

Credits: ANI

As of 12pm on November 22, Delhi's AQI according to aqi.in is recorded at 315, with PM2.5 recorded at 225, and PM10 recorded at 296. The levels are still under the category 'Hazardous' and is equivalent to smoking 10.8 cigarettes a day, 75.6 cigarettes a week, and 324 cigarettes a month.

Amid all this, in an interview with the news agency ANI, AIIMS doctor called Delhi's deteriorating air quality as a "medical emergency". The doctors have warned that the crisis has intensified to a level where existing government measures are no longer enough. Prof Dr Anant Mohan, who heads the Department of Pulmonary, Critical Care, and Sleep Medicine, and Dr Saurabh Mittal of the same department at AIIMS said that city's continuously worsening pollution could pose serious threats to the vulnerable, including pregnant women, unborn and newborn child, and other adults, especially the ones with cardiac or neurological conditions.

Impact Could Be Generational

Dr Mohan highlighted that the exposure could lead to impacts which could be felt for generations. He said that the alarming effect is being seen on pregnant women, and that the pollutant, since the particles are so small, could pass through mother to the child in the fetus and could affect their growth.

The doctor pointed out that babies who are exposed to such a condition in womb have a higher chance of being born under weight, and their lungs may continue to remain weak as they grow. There could be other complications too, which might only be noted as the child grows old.

Dr Mittal said that the effects of air pollution now reach far beyond respiratory issues. He noted that prolonged exposure to toxic air has triggered rising cases of breathlessness, lung inflammation, asthma attacks, and chronic conditions like COPD. Fine particulate matter is also entering the bloodstream, raising the risk of heart attacks and strokes.

What Can You Do?

Wear N-95 Mask

The doctors are advising to wear an N-95 mask whenever someone is stepping outdoors. He mentions that a cloth or a surgical mask won't protect them against the pollutants, as N-95 masks are the only protective gears with filters that can keep the pollutants out when you breathe.

Skip Your Morning Walk

Pollution is the highest in the morning. This happens because pollutants accumulate overnight, and without wind or sunlight, PM2.5 or the particulate matter stays trapped near the ground, leading to pollution being at its peak by sunrise. As per the data by aqi.in, highest AQI is always registered between 6am to 9am.

Use Wet Mopping

Dry dusting could push the particles back up into the air, thus using a wet mop would reduce the dust particles and prevent it from being released in the air.

Vitamin C Supplements

A 2007 study published in the Journal of the Royal Society of Medicine noted that vitamin C or its supplement could in fact help patients with pneumonia or other lung-related disease. Thus vitamin C is a good boost for when lungs are at high risk, all thanks to the pollution.

Furthermore, the doctors suggest to keep hydrating yourself and use air purifier if one can afford it.

End of Article

First Human Case Of H5N5 Bird Flu, Dies

Updated Nov 22, 2025 | 11:04 AM IST

SummaryThe first human case of H5N5 bird flu was confirmed in Washington, where an older patient with underlying conditions died. H5N5 has never infected humans before, though bird flu continues spreading in animals. Over 70 U.S. cases, mostly mild, involve other strains. Officials say public risk remains low but evolving.
First Human Case Of H5N5 Bird Flu, Dies

Credits: Canva

The first known human infected with the H5N5 strain of bird flu has died, Washington state health officials confirmed on Friday.

The patient was an older adult with underlying health conditions and had a backyard flock of mixed domestic birds, according to the Washington State Department of Health. No additional personal details were released out of respect for the family’s privacy.

A Rare Strain Never Before Seen in Humans

While the U.S. has recorded around 70 human bird flu cases over the past 18 months, all linked to the H5N1 strain, this is the first time H5N5 has been detected in a person. The strain has appeared in animals before but has never crossed over to humans until now.

Health officials emphasized that the risk to the public remains low. No close contacts have tested positive, and there is currently no evidence of human-to-human transmission.

Bird Flu Continues to Spread in Animals

Avian influenza has circulated in birds for decades, but its spread into mammals across the U.S. has accelerated. In March 2024, the U.S. Department of Agriculture confirmed that a bird flu strain affecting millions of birds had also been found in several mammals.

Since then, at least 70 people in the U.S. have tested positive for bird flu, mostly after exposure to infected cattle, poultry farms, or culling operations. The majority of cases have been mild, with symptoms like fever and red eyes, though some have been more severe. In January, the U.S. reported its first bird flu–related death in an older patient with underlying conditions.

Public Health Risk Remains Low

The CDC and other health agencies stress that there is no sign of the virus spreading between people. For now, the risk to the general public remains low, though surveillance continues as the virus evolves.

What Is Bird Flu?

Bird flu spreads from bird droppings and saliva. This happens especially when they feed on birdfeed and water.

Authorities have expanded compulsory poultry housing measures—previously limited to the North, Midlands and East—to all of England starting Thursday, in an effort to curb disease transmission. A nationwide Avian Influenza Prevention Zone also remains in force, mandating stringent biosecurity and hygiene protocols.

Health and Me had earlier reported that the UK had ordered 5 million vaccines against bird flu, also dubbed as "one mutation from being the next COVID". The comparison of bird flu with COVID, comes from the mutation that has recently been seen in the avian flu, which has affected animals and humans alike. Similar to how the corona virus previously also mutated, and continues to do so.

What are the symptoms one must look out for?

  • Pink eye
  • fever
  • fatigue
  • cough
  • muscle aches
  • sore throat
  • nausea
  • vomiting
  • diarrhea
  • study or runny nose
  • shortness of breath

Birds flu in humans

The first case of the recent bird flu outbreak in the US came in September, from a Missouri resident. However, the person did not have any exposure to infected animals. This is what is also raising the concern for mutation and the possibility of other forms of spreading. This was also a rare case as the infection did not happen due to exposure. Previously, all such cases in the US involved contact with farm animals or contaminated environment.

Can bird flu come from other animals?

Bird flu primarily infected farmworkers or those in close proximity to livestock. The first human bird flu case in the US was reported in 2022, to a person who was also involved in farm-working.

While this flu is largely confined to birds in the wild and poultry, recent outbreaks have been reported in mammals too, including cattle.

While 14 cases are in the US, the CDC notes that the risk to the general public is still at low, however, this warning could change. "Although human infections are rare, circumstances may evolve as we learn more about this case," said the CDC in a statement.

End of Article