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Refusal Reversal: Alkermes Review Back On Track, But Could Still Be Bumpy

 
• By Jessica Merrill

US FDA accepts Alkermes' NDA for depression drug after issuing refuse-to-file letter just two weeks ago; unusual move falls outside agency's guidance on RTFs because no changes were made to submission and it wasn't filed over protest.

In a surprising turn of events, the US FDA reversed its refuse-to-file decision on Alkermes PLC's depression drug ALKS 5461, but the quick change of course could mean the agency's questions will need to be addressed in the standard review process instead.

Alkermes announced April 16 that FDA has accepted an NDA for ALKS 5461 as an adjunctive therapy for the treatment...

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Where RWE Studies Stand In India And Bharat Serums’ Plans For The World’s Largest One

 
• By Vibha Ravi

Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds

Patient Perception-Of-Change Videos Not Efficacy Evidence For Stealth Barth Syndrome Drug

 
• By Sue Sutter

FDA reviewers cited several limitations of the videos, including a lengthy recall period, use of the term “today” in questions, and a lack of standardization in interview conduct.

Forzinity Chronology: Stealth’s Barth Syndrome Drug Bounced Around US FDA Review Divisions

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the clinical development and US FDA review timeline for Stealth's elamipretide for Barth syndrome.

With Forzinity, US FDA Accelerated Approval Still Can Precede Confirmatory Trial Enrollment

 
• By Sue Sutter

Stealth BioTherapeutics' diligent response to the FDA’s accelerated approval suggestion, its justification for proposed confirmatory trial milestones, and the rarity of Barth syndrome gave the agency confidence to grant approval before the postmarketing study began.

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NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.