Alnylam's (ALNY) Onpattro sNDA Gets FDA Advisory Committee Nod
Alnylam Pharmaceuticals, Inc. ALNY announced positive outcome from its meeting with the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) to discuss the impending supplemental new drug application (sNDA) for patisiran. The CRDAC is the FDA’s distinguished panel of independent experts.
Per Alnylam, out of 12 expert panelists in the committee, nine voted in favor of the company, indicating that the benefits of patisiran outweigh its risks for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.
The CRDAC’s opinion, although not binding, will be considered by the FDA in the decision-making process for the potential expanded indication for patisiran. A final decision from the regulatory body is still expected on Oct 8, 2023.
Patisiran is currently marketed as Onpattro in the United States and Europe for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults. Onpattro is the first and only FDA-approved treatment for this indication.
Year to date, shares of Alnylam have declined 10.9% compared with the industry’s 13.1% fall.
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Per ALNY, the positive opinion of the CRDAC was based on a discussion of the data submitted to support the sNDA for patisiran. Such data included positive results from the phase III APOLLO-B study of patisiran to treat the cardiomyopathy of ATTR amyloidosis.
In August 2022, the company reported that the APOLLO-B study met its primary endpoint of change from baseline in the 6-Minute Walk Test (6-MWT) versus placebo at 12 months. The study also met the first secondary endpoint of change from baseline in quality of life versus placebo. This demonstrated the favorable effects of treatment with patisiran on functional capacity and health status and quality of life in patients with ATTR amyloidosis with cardiomyopathy against placebo, as measured by the 6-MWT and the KCCQ-OS score, respectively.
Furthermore, in May 2023, the company announced new positive results from an interim analysis of exploratory data from the open-label extension (OLE) period of the phase III APOLLO-B study of patisiran for the treatment of ATTR amyloidosis with cardiomyopathy.
The interim analysis was carried out on the 18-month data of the APOLLO-B study. Results indicated that the previously achieved primary endpoint, health status and quality of life, observed at the end of 12 months of the same study, were sustained with continued treatment with patisiran during the OLE period (at the end of 18 months).
Alnylam has reportedly submitted the 18-month data from the interim analysis of the OLE period to the FDA as an amendment to the sNDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis.
A label expansion of Onpattro is likely to offset, to some extent, the declining revenue trend from its sales, as more and more patients are switching to Amvuttra (vutrisiran). Amvuttra received the FDA approval in June 2022, for the treatment of adult patients with polyneuropathy of hereditary ATTR (hATTR) amyloidosis. Amvuttra is also approved in the EU for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
In a separate press release, Alnylam announced that NASDAQ had halted trading of its common stock on Sep 13, 2023, in anticipation of the company’s meeting with the FDA’s advisory committee regarding the patisiran sNDA.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Alnylam currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector are Dynavax Technologies DVAX, Corcept Therapeutics CORT and Better Therapeutics BTTX, each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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