May FDA Approval Wave: Key Decisions Loom for Blockbuster Drug Candidates

May 05, 2025 13:46 CST Updated 13:46

GSK

Pharmaceutical R&D Manufacturer

Sanofi

Pharmaceutical Manufacturer

In May, the U.S. Food and Drug Administration (FDA) enters a critical period for a batch of key drug approval decisions, involving important products from several well-known pharmaceutical companies such as GSK, Sanofi, and Merck. These approval outcomes are not only crucial for corporate development but will also have a significant impact on the treatment landscape of related diseases.

New Indication for Asthma Drug: GSK Challenges COPD Treatment Field

GSK Seeks FDA Approval for Asthma Injection Drug Nucala to Treat Chronic Obstructive Pulmonary Disease (COPD); FDA Decision Expected on May 7

Dermatology Drug Expansion: Arcutis Targets More Psoriasis Patients

On May 22, the FDA will make a decision on Arcutis Biotherapeutics' application to expand the use of Zoryve for body and scalp psoriasis. Zoryve is a topical phosphodiesterase 4 inhibitor that works by reducing skin inflammation and has been approved since 2011 for treating plaque psoriasis in patients aged 12 years and older. This time, Arcutis is submitting its expansion application based on Phase III ARRECTOR trial data, which showed that 66.4% of patients treated with Zoryve achieved clear or almost clear skin, compared to only 27.8% in the placebo group. Additionally, 65.3% of patients in the Zoryve group experienced significant improvement in itching symptoms, versus just 30.3% in the placebo group. If approved, this would provide a new treatment option for patients with poorly controlled symptoms.

Vaccine Target Population Expansion: Sanofi Focuses on Infant and Toddler Health

Sanofi's Meningococcal Disease Vaccine MenQuadfi Approved for Primary Immunization in Children Aged 2 Years and Above, and Booster Immunization in Individuals Aged 13 Years and Above at Continued Risk of Infection. Sanofi Aims to Expand its Use to Infants Aged 6 Weeks to 23 Months, with the FDA Expected to Announce Approval Decision on May 23. In April, Sanofi Presented Multiple Trial Data to the CDC’s Advisory Committee on Immunization Practices, Including Phase III MET42 Study Results Showing that MenQuadfi is Safe for Use in Infants, with Most Side Effects Being Mild or Moderate. Its Immune Response and Seroprotection Were Comparable to Commercially Approved Vaccines. If Approved, It Will Offer Protection Against Neisseria meningitidis Serogroups A, C, W, and Y for Children in This Age Group.

New Pulmonary Drug Approval on the Horizon: Liquidia Pushes for Final Approval

Liquidia's inhaled powder drug Yutrepia, used to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD), is expected to receive final FDA approval on May 23. In August 2024, the FDA granted the drug tentative approval, indicating that it has met the standards for efficacy, safety, and product quality, but must wait for the regulatory exclusivity period of competing products to end. Yutrepia is an inhaled formulation of treprostinil. The Phase III INSPIRE study showed that the drug demonstrated good safety and tolerability in patients who were either new to treprostinil or transitioning from nebulized treprostinil, with patients experiencing stabilization or improvement in symptoms after one year of treatment.

New Journey for Anti-Cancer Drugs: Merck Expands the Application Scope of Welireg

Merck Hopes to Expand the Use of Its Oral Anticancer Drug Welireg to Advanced Pheochromocytoma and Paraganglioma (PPGL), with FDA Decision Due on May 26. PPGL are two rare adrenal tumors, with about 2,000 patients diagnosed annually, usually caused by specific genetic mutations, and some already metastatic at diagnosis. Merck’s application is based on data from the Phase II LITESPARK-015 study, A1 cohort. Though specific data has not been disclosed, the FDA has granted priority review for this application. Welireg is an oral inhibitor of the HIF-2α transcription factor, currently approved for renal cell carcinoma and Von Hippel-Lindau disease associated with renal cell carcinoma. If approved, it will become the first drug in the U.S. for advanced PPGL.

Progress in Pediatric Drug Approval: Eton Awaits Final Verdict

Eton Pharmaceuticals' oral hydrocortisone ET-400, for the treatment of infant adrenal insufficiency, is awaiting an FDA decision scheduled for release on May 28. The FDA had previously delayed its decision to allow more time for data review, and Eton submitted additional information in December. ET-400 is a room-temperature stable oral hydrocortisone formulation, and if approved, it will join Eton's already approved Alkindi Sprinkle (hydrocortisone oral granules) in expanding the company’s share of the oral hydrocortisone market. Eton anticipates that these two products could generate over $50 million in peak annual revenue for the company.

COVID-19 Vaccine Upgrade: Moderna Seeks Next-Generation Breakthrough

Moderna's Next-Generation COVID-19 Vaccine mRNA-1283 Awaits FDA Decision on May 31

The FDA approval wave in May has drawn significant attention, as the outcomes of these drug approvals will reshape the treatment landscape for related diseases in the coming period. This holds profound implications for patients, pharmaceutical companies, and the entire healthcare industry, with all sectors closely watching the final decisions.

Reference Source:https://www.biospace.com/fda/fda-action-alert-gsk-sanofi-merck-and-more

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