Logo

FDA Approves Merck’s Enflonsia RSV Shot for Infants, Boosting Market Competition

Merck's Enflonsia, a newly FDA-approved monoclonal antibody shot, promises protection for infants against RSV during their first viral season. The drug’s launch ahead of the fall-winter RSV period sets the stage for competition with Sanofi and AstraZeneca’s Beyfortus, especially as supply and dosing conveniences play key roles. Clinical trials showcased impressive reductions in hospitalizations, marking a vital step in RSV prevention.

FDA Approves Merck’s Enflonsia RSV Shot for Infants, Boosting Market Competition

FDA Greenlights Merck’s Enflonsia to Shield Infants from RSV

The Food and Drug Administration has given the nod to Merck’s new respiratory syncytial virus (RSV) antibody shot, Enflonsia, designed to protect infants during their first RSV season. This approval allows Merck to release the drug in time for the upcoming RSV season, which usually hits in fall and winter and extends into spring.

What This Means for Parents and Healthcare Providers

Merck expects to begin taking orders as early as July, aiming to deliver doses before RSV widely spreads. RSV remains a serious threat, causing thousands of deaths in older adults and hundreds in infants annually, with complications being the leading reason for hospitalizations among newborns.

Dr. Dean Li, president of Merck Research Laboratories, emphasized the company’s commitment to making Enflonsia accessible ahead of the season to ease the burden of this widespread infection on families and healthcare systems.

Competition Intensifies: Enflonsia vs. Beyfortus

Enflonsia enters a market where it will face direct competition from Beyfortus, a similar monoclonal antibody treatment developed by Sanofi and AstraZeneca. Beyfortus experienced nationwide shortages during last year’s unprecedented demand surge.

While both drugs provide immediate protection by delivering antibodies directly into the bloodstream, they target different parts of the RSV virus, making direct comparisons complex. One notable advantage of Enflonsia is its administration independent of infant weight, potentially simplifying dosing. Beyfortus requires dosing adjusted by the infant’s body weight.

Market Dynamics and Supply Updates

Sanofi has announced efforts to boost Beyfortus supplies, including plans to begin early third-quarter shipments. The drug generated sales of approximately €1.7 billion (around $1.8 billion) last year, reflecting its blockbuster status.

Overview of RSV Prevention Options

Beyond monoclonal antibodies, RSV vaccines exist for adults and pregnant women but are not approved for young children. Recently, the FDA paused approvals for RSV shots in young children amid ongoing safety evaluations.

All manufacturers are now awaiting a critical meeting of external vaccine advisors to the Centers for Disease Control and Prevention, scheduled from June 25 to 27. This panel will recommend immunization policies concerning RSV and related vaccines.

Clinical Trial Success

Mid- to late-stage trials for Enflonsia revealed promising results: it led to an 84% reduction in RSV-related hospitalizations and a 90% decrease in hospitalizations due to lower respiratory infections in infants up to five months old compared with placebo. Additionally, the shot cut lower respiratory infections requiring medical care by over 60% during this period.

Why RSV Protection Matters

RSV is a common cause of lower respiratory infections such as pneumonia, especially threatening to infants and older adults. New preventive measures, like Enflonsia, represent critical advancements in reducing these infections and their associated hospitalizations.

Stay tuned for further updates as this new treatment rolls out and the CDC formulates its immunization guidelines.

Dr. Reddy’s Eyes Major Growth with Generic Weight-Loss Drug Rollout by 2026
Dr. Reddy’s Eyes Major Growth with Generic Weight-Loss Drug Rollout by 2026

With obesity and diabetes rates soaring worldwide, Dr. Reddy’s Laboratories is seizing a unique opportunity by introducing generic versions of semaglutide across emerging markets by 2026. This move could lower drug costs, expand access to effective therapies, and generate significant revenue, while challenging established pharmaceutical giants like Novo Nordisk and Eli Lilly. Experts highlight this as a pivotal moment for global health equity in chronic disease treatment.

Novo Nordisk Cuts Ties with Hims & Hers Over Wegovy Copycat Sales
Novo Nordisk Cuts Ties with Hims & Hers Over Wegovy Copycat Sales

Novo Nordisk has ended its partnership with telehealth company Hims & Hers after uncovering unauthorized sales and promotion of cheaper, compounded versions of the weight loss drug Wegovy. This move comes amid tightening legal restrictions post-drug shortage and concerns over patient safety tied to unregulated counterfeit products sourced from uninspected foreign manufacturers. Following the announcement, Hims & Hers shares plunged almost 20%, highlighting the serious impact of these compliance issues.

Hims & Hers to Launch Affordable Generic Semaglutide in Canada After Novo Nordisk Patent Expiry
Hims & Hers to Launch Affordable Generic Semaglutide in Canada After Novo Nordisk Patent Expiry

With Novo Nordisk’s patent on semaglutide drugs Ozempic and Wegovy expiring in Canada, telehealth firm Hims & Hers announces plans to provide generic semaglutide in 2026. This move could drastically reduce treatment costs and improve access for Canadians battling obesity and diabetes. The unexpected patent lapse, due to unpaid fees, opens a competitive market previously dominated by high-priced originals, raising questions about drug pricing, regulatory approval, and the evolving role of telehealth in medication delivery.

Bristol Myers Squibb and Pfizer Cut Eliquis Price by Over 40% for Direct Patient Sales
Bristol Myers Squibb and Pfizer Cut Eliquis Price by Over 40% for Direct Patient Sales

Pharma leaders Bristol Myers Squibb and Pfizer announce a new program selling their blood thinner Eliquis directly to certain patients at a 40% discount, bypassing insurers and middlemen. While offering relief to uninsured and underinsured patients, the move raises questions about drug affordability and systemic pricing disparities amid evolving U.S. healthcare policies.

Trump Administration Cancels $700M Moderna Bird Flu Vaccine Funding
Trump Administration Cancels $700M Moderna Bird Flu Vaccine Funding

The Trump administration has rescinded more than $700 million in funding previously awarded to Moderna to develop its bird flu vaccine, including procurement rights. Earlier funding from both the Biden administration and the Department of Health and Human Services supported late-stage trials of Moderna's H5N1 vaccine. Despite cancellation, Moderna's mid-stage trials show positive results, and the company seeks alternative development options.

FDA Greenlights Gilead’s Twice-Yearly HIV Prevention Injection
FDA Greenlights Gilead’s Twice-Yearly HIV Prevention Injection

Gilead’s long-acting HIV prevention injection, Yeztugo, has secured FDA approval, delivering potent protection with just two doses annually. Despite clinical success and broad insurance efforts, proposed federal funding cuts pose risks to accessibility, especially for vulnerable communities disproportionately affected by HIV. The company pledges expanded global supply and affordability initiatives.

World Elders Abuse Awareness Day Rally Highlights Senior Citizens’ Struggles
World Elders Abuse Awareness Day Rally Highlights Senior Citizens’ Struggles

On World Elders Abuse Awareness Day, Vizianagaram’s Senior Citizens Welfare Association organized a rally to highlight the growing challenges faced by elderly individuals, including verbal abuse, forced isolation, and insufficient healthcare support. Leaders urged the government to ensure dignity and comprehensive care for senior citizens.

Drone Attack on Sudan Hospital Kills Six Amid Ongoing Conflict
Drone Attack on Sudan Hospital Kills Six Amid Ongoing Conflict

A suspected drone attack conducted by paramilitary forces targeted Obeid International Hospital in North Kordofan, Sudan, resulting in six deaths and multiple injuries. The strike caused severe structural damage, forcing the hospital to cease operations. Occurring amid Sudan’s civil war between the military and Rapid Support Forces, the assault adds to a growing list of violent incidents destabilizing the region and exacerbating a dire humanitarian crisis.

CDC Panel Endorses Merck’s RSV Shot for Infants in Major Health Move
CDC Panel Endorses Merck’s RSV Shot for Infants in Major Health Move

The CDC’s revamped vaccine advisory panel has unanimously recommended Merck’s RSV shot, Enflonsia, for infants during their first RSV season. Despite recent leadership changes and some opposition, the injection demonstrated over 84% reduction in RSV hospitalizations. The move enables wide access to this critical preventive measure ahead of the virus season.

Breakthrough Malaria Treatment for Infants Approved, Set to Launch in Africa
Breakthrough Malaria Treatment for Infants Approved, Set to Launch in Africa

Swiss regulators have endorsed Coartem Baby, the world’s first malaria treatment designed for infants under 4.5 kg. Developed by Novartis and MMV with African partners, the formulation aims to save lives in malaria-stricken regions by bridging a long-standing treatment gap. With distribution on a not-for-profit basis, this milestone could significantly reduce child mortality in Africa, where malaria remains a leading killer of young children.

Merck Acquires UK Lung Therapy Firm Verona for $10 Billion to Boost Respiratory Portfolio
Merck Acquires UK Lung Therapy Firm Verona for $10 Billion to Boost Respiratory Portfolio

Merck announced a $10 billion acquisition of London-based Verona Therapeutics, aiming to strengthen its respiratory disease treatments portfolio. The deal boosts Merck's diversification strategy beyond its flagship cancer drug Keytruda, which faces patent expiration from 2028. Verona’s inhalable, non-steroid COPD treatment Ohtuvayre shows blockbuster potential, promising growth in a market affecting millions of Americans.

Paraguay President's X Account Targeted in Bitcoin Scam Hack
Paraguay President's X Account Targeted in Bitcoin Scam Hack

Paraguay’s government confirmed suspicious activity on President Santiago Pena's X account, suspected to be a hack promoting a fake Bitcoin legal tender announcement and reserve fund. Authorities are investigating alongside X’s cybersecurity team, urging citizens to disregard any posts until the issue is resolved.

700 Marines Deployed Amid LA Immigration Protests; California Sues Federal Govt
700 Marines Deployed Amid LA Immigration Protests; California Sues Federal Govt

Los Angeles is witnessing heightened tensions following immigration raids that sparked protests and violence. The federal government deployed 700 Marines alongside National Guard troops, prompting California’s governor to denounce the move as illegal and sue the administration. Despite clashes, most protests remain peaceful, as national and international voices call for restraint.