FDA Greenlights Nucala as New Treatment for COPD

Updated May 24, 2025 | 08:00 AM IST

SummaryFDA approves Nucala as add-on therapy for COPD with high eosinophils, offering new hope by reducing flare-ups in patients unresponsive to inhaled treatments.
FDA approves Nucala as add-on therapy for COPD with high eosinophils, offering new hope by reducing flare-ups in patients unresponsive to inhaled treatments.

Credits: Canva

The U.S. Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) that remains inadequately controlled despite existing therapies. The approval offers new hope to patients whose symptoms persist despite being on inhaled triple therapy.

What is COPD?

According to the World Health Organization (WHO), COPD is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. It typically results from significant exposure to noxious particles or gases.

Symptoms of COPD include:

  • Chronic cough
  • Shortness of breath
  • Wheezing
  • Chest tightness
  • Excess mucus production

Causes of COPD range from long-term smoking and air pollution exposure to occupational dusts and fumes. Genetics and respiratory infections in early life can also contribute.

COPD is progressive and often worsens over time, severely impacting quality of life. One of the most critical challenges in managing the condition is reducing exacerbations—flare-ups that may require hospitalization or emergency treatment.

Why Nucala Matters

Nucala is the only approved biologic that has been specifically studied in COPD patients with an eosinophilic phenotype defined by a blood eosinophil count (BEC) of ≥150 cells/μL. This is important because up to 70% of U.S. COPD patients who are not adequately managed on inhaled triple therapy fall into this category.

Biologics like Nucala work by targeting specific pathways in the immune system. Mepolizumab, the active ingredient in Nucala, is an anti-IL-5 monoclonal antibody that reduces eosinophilic inflammation—a key contributor to COPD exacerbations in certain patients.

Clinical Trial Evidence

The FDA’s approval of Nucala is based on results from two large Phase 3 clinical trials, MATINEE and METREX, which evaluated its use alongside optimal inhaled therapy. Both were randomized, double-blind, and placebo-controlled.

In the MATINEE trial, involving 804 patients with a BEC ≥300 cells/μL, Nucala showed:

A significant reduction in moderate or severe exacerbations: 0.80 vs 1.01 events/year (rate ratio, 0.79).

A 35% decrease in emergency visits or hospitalizations for COPD exacerbations (rate ratio, 0.65).

The METREX trial produced similar outcomes. Patients on Nucala had:

Fewer moderate or severe exacerbations: 1.40 vs 1.71 events/year (rate ratio, 0.82).

Adverse events were comparable between the Nucala and placebo groups, suggesting a favorable safety profile.

A New Era for COPD Management

“COPD isn't just a disease, it's a relentless cycle,” said Dr. Jean Wright, CEO of the COPD Foundation. “Even with current therapies, managing exacerbations remains a daily battle. Biologics like mepolizumab offer new hope.”

The FDA approval was granted to GSK, the pharmaceutical company that developed Nucala. With this decision, clinicians now have a novel option for patients with eosinophilic COPD who are still struggling despite standard treatment.

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Nine-month-old Child Tested Positive For Covid-19 In Bengaluru

Updated May 24, 2025 | 04:00 PM IST

SummaryA 9-year-old child has been tested positive for Covid-19 in Bengaluru. This has made many other vigilant for the ongoing wave of the Covid-19 virus. Here's all that you need to know.
Nine-month-old Child Tested Positive For Covid-19 In Bengaluru

Credits: Canva

A nine-month-old baby boy from Hoskote in Bengaluru Rural district has tested positive for Covid-19, according to Karnataka’s Health and Family Welfare Department. The infant was initially taken to a private hospital but later transferred to Vani Vilas Hospital in Kalasipalya, Bengaluru, for specialized care.

The child tested positive through a Rapid Antigen Test conducted on May 22. Officials confirmed that the baby is in stable condition and under close medical observation. Doctors at the hospital say he is responding well to treatment.

Covid-19 Situation in Karnataka

The case comes at a time when Karnataka is witnessing a slight but noticeable increase in Covid-19 cases. As of now, the state has 35 active infections, with 32 of them reported in Bengaluru alone. So far, no fatalities have been linked to the recent surge.

Health authorities noted a gradual uptick in cases over the last 20 days, prompting reminders to the public to follow Covid safety protocols. People have been advised to wear masks in crowded places, maintain hygiene, and avoid unnecessary gatherings—particularly in cities like Bengaluru, where the majority of cases are being reported.

Rise in Cases in Kerala

Neighbouring Kerala has experienced a sharper rise in infections this month, with 182 confirmed cases so far. The state’s Health Minister has urged residents to remain alert and take precautionary measures. Among the districts, Kottayam has recorded the highest number of infections (57), followed by Ernakulam (34) and Thiruvananthapuram (30).

In response, Kerala’s health authorities have stepped up public messaging to promote early testing and isolation to limit the spread of the virus.

ALSO READ: 23 New Covid Cases In Delhi, Health Minister Issues Advisory

Andhra Pradesh Issues Public Advisory

In Andhra Pradesh, the Health Department released a public advisory on May 22 following indications of a rise in Covid-19 cases. Although specific figures have not been released, officials have recommended that people stay cautious, get tested if they show symptoms, and continue following preventive practices such as masking and hand hygiene.

Advisory For Delhi Hospitals

In an internal order, Delhi’s health department directed all hospitals to ensure critical equipment like ventilators, BiPAP machines, and oxygen concentrators are functional. Staff are being asked to undergo refresher training, and all hospitals must report Influenza-like Illness (ILI) and Severe Acute Respiratory Illness (SARI) cases daily on the Integrated Health Information Platform (IHIP).

Additionally, 5% of ILI cases and 100% of SARI cases must undergo COVID-19 testing, in accordance with ICMR guidelines. Positive samples are to be sent to Lok Nayak Hospital for genome sequencing to detect any emerging variants.

Cases Originally From Singapore And Hong Kong

Singapore and Hong Kong are witnessing a noticeable surge in COVID-19 cases, primarily driven by LF.7 and NB.1.8 sub-variants. Singapore’s Ministry of Health has urged citizens to get vaccinated, especially those who haven’t received their initial doses. Hong Kong has reached its highest case numbers in over a year and is encouraging mask-wearing and crowd avoidance.

What Are the Current Symptoms?

Unlike earlier variants, the current wave presents some slightly different symptoms. While cough and sore throat remain common, additional symptoms include nausea, vomiting, brain fog, and conjunctivitis. Most cases are mild, but health authorities advise individuals to monitor symptoms and seek medical attention if needed.

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23 New Covid Cases In Delhi, Health Minister Issues Advisory

Updated May 24, 2025 | 09:00 AM IST

SummaryThe number of COVID-19 cases remains low and most are mild, Delhi and other states have ramped up hospital preparedness and surveillance. The new wave, driven by Omicron’s JN.1 sub-variants, is being closely monitored, and public health officials continue to stress vigilance over panic.
23 New Covid Cases In Delhi, Health Minister Issues Advisory

Credits: Canva

New Delhi is witnessing a modest increase in COVID-19 cases, with 23 active infections reported as of May 22, Health Minister Dr. Pankaj Singh confirmed on Friday. Emphasizing that there is no reason to panic, Singh said all patients are currently stable. “Two to three patients are admitted to private hospitals while the others are being monitored. We will verify if these patients are residents of Delhi or from outside. The strain is similar to influenza,” he noted.

The minister also reassured the public about the state’s preparedness. “We’ve had conversations with medical superintendents. Eight senior officials are visiting hospitals daily to ensure everything is in order. Our hospitals are equipped with oxygen, oximeters, and essential medical supplies,” Singh added.

In line with this, the Delhi health department has instructed all private and government hospitals to ensure the availability of beds, oxygen, essential medicines, and vaccines. An advisory will be issued shortly to provide further guidance.

Omicron Sub-Variants Fuel Regional and Global Spike

The rise in COVID-19 cases in Delhi and other Indian states comes after a spike was observed in several Asian countries. Health authorities have attributed the increase to Omicron-related sub-variants—primarily LF.7 and NB.1.8—descendants of the JN.1 variant, which in turn evolved from the BA.2.86 (Pirola) strain.

These sub-lineages are known for their high transmissibility but relatively mild symptoms. Despite the rise, experts maintain that the current wave is manageable and no immediate threat of severe disease has been identified.

Advisory To Hospitals

In an internal order, Delhi’s health department directed all hospitals to ensure critical equipment like ventilators, BiPAP machines, and oxygen concentrators are functional. Staff are being asked to undergo refresher training, and all hospitals must report Influenza-like Illness (ILI) and Severe Acute Respiratory Illness (SARI) cases daily on the Integrated Health Information Platform (IHIP).

Additionally, 5% of ILI cases and 100% of SARI cases must undergo COVID-19 testing, in accordance with ICMR guidelines. Positive samples are to be sent to Lok Nayak Hospital for genome sequencing to detect any emerging variants.

Neighboring States And Others Also Report Mild Cases

Haryana: Two mild COVID-19 cases were reported in Gurgaon—a 62-year-old man and a 31-year-old woman who had recently travelled from Mumbai. Both are in home isolation. Meanwhile, a 28-year-old security guard from Faridabad tested positive at Delhi’s Safdarjung Hospital. None had a travel history abroad or known contact with infected persons. Health officials emphasized that these are isolated, mild cases and do not indicate a severe outbreak.

Maharashtra: The state has reported 95 new COVID-19 cases in Mumbai this month, with a total of 106 since January. At least 16 patients are hospitalized, mostly shifted to Seven Hills Hospital from KEM Hospital. Pune, although not reporting any active cases currently, has reserved 50 beds at Naidu Hospital as a precautionary step.

Tamil Nadu: In Chennai and Puducherry, health officials are seeing a shift in viral diagnosis, where fevers initially linked to influenza are now being identified as COVID-19. Public Health Director Dr. TS Selvavinayagam has urged caution in crowded places but reassured the public not to panic.

Karnataka: The state currently has 16 active COVID-19 cases, confirmed by Health Minister Dinesh Gundu Rao.

Gujarat: Seven new cases were reported in Ahmedabad in a single day—a sharp spike for a city that has averaged one case per month over the past year. All patients are in home isolation, and their samples have been sent for genomic sequencing. Officials say the infections are from the JN.1 variant and are mild in nature.

International Spike

Singapore and Hong Kong are witnessing a noticeable surge in COVID-19 cases, primarily driven by LF.7 and NB.1.8 sub-variants. Singapore’s Ministry of Health has urged citizens to get vaccinated, especially those who haven’t received their initial doses. Hong Kong has reached its highest case numbers in over a year and is encouraging mask-wearing and crowd avoidance.

What Are the Current Symptoms?

Unlike earlier variants, the current wave presents some slightly different symptoms. While cough and sore throat remain common, additional symptoms include nausea, vomiting, brain fog, and conjunctivitis. Most cases are mild, but health authorities advise individuals to monitor symptoms and seek medical attention if needed.

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Baby Food Pouches Recalled Due To Elevated Lead Levels

Updated May 24, 2025 | 07:00 AM IST

SummaryA supermarket chain has recently recalled its baby food pouches finding elevated lead levels. While contaminated pouches were being sold in eight states; no illnesses have been reported so far.
Baby food recalled

Credits: Canva

While in the cases of listeria and other food-related diseases, products are recalled. In another news, supermarket chain Publix has issued a recall for its Greenwise Pear, Kiwi, Spinach & Pea Baby Food pouches after routine product testing detected elevated levels of lead, federal health officials announced. The affected items were sold across eight states in more than 1,400 Publix stores.

What Prompted the Recall?

The 4-ounce baby food pouches, manufactured by Bowman Andros—a French company with a production facility in Mount Jackson, Virginia—were voluntarily recalled by Publix on May 9. However, the recall wasn’t listed on the U.S. Food and Drug Administration (FDA) website until late Thursday.

Testing by North Carolina officials—the same team that first discovered a widespread 2023 lead contamination in applesauce pouches—detected 13.4 parts per billion (ppb) of lead in the product. This exceeds the FDA's recommended limit of 10 ppb for food consumed by infants and young children.

No Reported Illnesses Yet

While no health issues have been reported in connection with this product, Publix has removed all possibly contaminated pouches from store shelves. Customers are encouraged to return them for a full refund.

This is the second recall in two months involving baby food pouches due to lead contamination. In March, Target recalled over 25,000 units of its Good & Gather Baby Pea, Zucchini, Kale & Thyme Vegetable Puree for the same reason.

A Wider Concern

North Carolina continues to partner with the FDA to conduct routine food safety testing. The state played a key role in the 2023 lead poisoning investigation involving WanaBana Apple Cinnamon Fruit Puree, which was linked to over 500 cases of illness across 44 states. Those pouches contained lead levels up to 2,000 times the FDA’s safety limit and were found to contain chromium as well.

The Centers for Disease Control and Prevention (CDC) led the response during that outbreak, identifying 566 confirmed, probable, or suspected cases. However, the CDC’s childhood lead poisoning prevention program was cut in April during federal budget reductions under the Trump administration. A CDC spokesperson confirmed the agency is aware of the Publix recall but has not been asked to investigate.

Why Lead Is Dangerous

According to the CDC, no level of lead exposure is safe, especially for children. Lead can cause serious neurological and developmental damage, including learning disabilities and delayed growth.

The American Academy of Pediatrics notes that heavy metals like lead can enter food through soil, water, air, or industrial contamination, making rigorous safety checks critical for baby food products.

Recently, to ensure that baby foods are produced ensuring the safety procedures, the US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) have now begun a comprehensive review of the nutritional value of infant formula. This program by the agencies is dubbed as Operation Stork Speed.

This operation aims to review the nutrient content of infant formula. How will it be done? The agencies will increase testing for heavy metals and contaminants in the formula. The agencies will also encourage companies to develop new formulas, and clarify ways to better inform consumers about their ingredients.

The individual nutrient requirements for infant formula are already reviewed at regular intervals, however, this will be the first comprehensive review since 1998.

As part of Operation Stork Speed, the FDA has issued a Request for Information (RFI) to solicit public input on the nutritional composition of infant formula.

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