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Merck’s Molnupiravir: Second COVID Pill Is Second-Line, But Timing Helps Both Sponsor And US FDA

 
• By Nielsen Hobbs

After lengthy review, Merck’s antiviral gets very restricted indication as part of its EUA, apparently reflecting concerns over safety and efficacy. But molnupiravir does appear to have some advantages over Pfizer’s Paxlovid – including that more of it will be available in the short term.

Molnupiravir capsules and bottle (Merck)
MOLNUPIRAR’S DOSING SCHEDULE IS FOUR PILLS, TWICE A DAY, FOR FIVE DAYS. • Source: Merck

The timing of the US Food and Drug Administration’s emergency use authorization for Merck & Co., Inc.’s COVID-19 treatment molnupiravir appears to have allowed the agency to craft a less complicated indication – though still not one that’s particularly favorable to the product.

Molnupiravir got its EUA on 23 December after a 74-day review – the second longest EUA review

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More from Approvals

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
• By Neena Brizmohun

The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

More from Product Reviews

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.