FDA's May Docket: Key Decisions on Horizon for Major Pharma Players

The U.S. Food and Drug Administration (FDA) is set to make several pivotal decisions this month, with potential approvals that could reshape treatment landscapes across various therapeutic areas. From expanding indications for established drugs to introducing novel therapies, May's FDA docket is packed with high-stakes rulings for pharmaceutical giants and smaller biotechs alike.

GSK and Merck Seek Label Expansions for Established Therapies

GlaxoSmithKline (GSK) is awaiting the FDA's verdict on May 7 for its asthma drug Nucala (mepolizumab) in chronic obstructive pulmonary disease (COPD). The company is proposing Nucala as a treatment for adult COPD patients with an eosinophilic phenotype. GSK's application is supported by data from the Phase III MATINEE trial, which demonstrated a significant reduction in moderate or severe disease exacerbations compared to placebo.

Meanwhile, Merck is looking to expand the label of its oral cancer drug Welireg (belzutifan) to include advanced pheochromocytoma and paraganglioma (PPGL). The FDA's decision, expected by May 26, could make Welireg the first approved drug for advanced PPGL in the United States. Merck's application is based on data from the Phase II LITESPARK-015 study, focusing on objective response rate and duration of response in PPGL patients.

Novel Therapies and Formulations Under Review

Liquidia Technologies is anticipating final approval for Yutrepia, an inhalation powder for pulmonary arterial hypertension associated with interstitial lung disease (PH-ILD), by May 23. The drug, an inhaled formulation of treprostinil, received tentative approval in August 2024 and has shown promising results in stabilizing or improving symptoms over one year of treatment in the Phase III INSPIRE study.

Eton Pharmaceuticals is nearing a potential approval for ET-400, an oral formulation of hydrocortisone for adrenal insufficiency in infants. The FDA's decision, due by May 28, follows a delay to review additional data submitted by the company. If approved, ET-400 would join Eton's Alkindi Sprinkle in addressing pediatric adrenocortical insufficiency.

Vaccine Developments: Sanofi and Moderna in the Spotlight

Sanofi is seeking to expand the label of its meningococcal disease vaccine MenQuadfi to include infants and toddlers from six weeks to 23 months of age. The FDA's decision, expected on May 23, could provide protection against four serogroups of Neisseria meningitidis for this younger population.

In the evolving COVID-19 landscape, Moderna awaits the FDA's verdict on its next-generation vaccine candidate, mRNA-1283, by May 31. The company claims the experimental shot elicited a higher immune response against SARS-CoV-2 compared to its current vaccine, Spikevax, particularly in seniors over 65 years of age.

As these decisions unfold, the pharmaceutical industry stands at the cusp of potential breakthroughs that could significantly impact patient care across multiple therapeutic areas. The outcomes of these FDA reviews will not only shape treatment options but also influence the strategic directions of the companies involved in the coming months.