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Alnylam (ALNY) Gets FDA Nod for Oxlumo to Treat Renal Disease

Zacks.com logo Zacks.com 11/25/2020

Alnylam Pharmaceuticals, Inc. ALNY announced that the FDA approved Oxlumo (lumasiran) injection for subcutaneous use, for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. The ultra-rare disease causes a progressive decline in kidney function and can lead to end-stage renal disease.

Oxlumo is the first RNAi therapeutic approved in the United States for use in both children and adults, and the third RNAi medicine to receive FDA approval in less than three years.

Shares of Alnylam have gained 9.2% year to date against the industry’s decline of 0.5%.

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The FDA approval was primarily based on positive results from ILLUMINATE-A, the largest controlled phase III study ever conducted in PH1 — where Oxlumo significantly reduced levels of urinary oxalate relative to placebo, with the majority of patients achieving normal or near-normal levels. The FDA also took into consideration positive interim results from the single-arm, open-label ILLUMINATE-B phase III pediatric study. 

With the approval of Oxlumo, the FDA granted Alnylam a pediatric rare disease priority review voucher that entitles the company to designate a single new drug application to qualify for a priority review in the future.

The company also announced a new framework for value-based agreements (VBAs) designed to help people with PH1 gain access to Oxlumo. The VBA framework includes an innovative patient need adjustment that offers payers increased cost predictability across the entire spectrum of PH1 patient ages, from infant to adult.

We remind investors that this month, the European Commission (EC) granted marketing authorization to Oxlumo for the treatment of PH1 in all age groups. 

Meanwhile, the company is also evaluating several other candidates. A few significant ones include vutrisiran and inclisiran. The company and partner Novartis’ NVS inclisiranis under review in the United States and Europe for treating heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease.

Alnylam has a collaboration with Regeneron Pharmaceuticals REGN to discover, develop and commercialize new RNAi therapeutics for a broad range of diseases by addressing disease targets expressed in the liver, eye and central nervous system.

Zacks Rank and A Stock to Consider

Alnylam currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the healthcare sector includes Alimera Sciences Inc. ALIM, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days. Shares of the company have decreased 38.6% year to date.

 

Alnylam Pharmaceuticals, Inc. Price

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