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

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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the European Commission (EC) has granted marketing authorization for Oxlumo (lumasiran), an RNAi therapeutic, for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.The ultra-rare disease causes a progressive decline in kidney function and can lead to end-stage renal disease.

Oxlumo is the first therapeutic approved for the treatment of PH1 and the only therapy proven to lower harmful oxalate levels that drive the progression of the PH1 disease.

Shares of Alnylam have gained 7.5% year to date against the industry’s decline of 1.7%.

The approval is supported by the efficacy and safety findings of Oxlumo in PH1 patients, including data from both ILLUMINATE-A and ILLUMINATE-B phase III studies. Key primary and secondary endpoints included the reduction of urinary and plasma oxalate and the proportion of patients achieving normalization or near-normalization of urinary oxalate in response to Oxlumo compared to placebo. This approval in the European Union follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in October 2020.

Oxlumo also enjoys the Priority Medicines (PRIME) designation by the EMA and the Orphan Drug designation in the European Union. Alnylam filed a new drug application (NDA) with the FDA. The FDA has granted a Priority Review to the NDA and set an action date of Dec 3, 2020.

Meanwhile, the company is also evaluating several other candidates. A few significant ones include vutrisiran and inclisiran. The company and partner Novartis’ (NVS - Free Report) 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 - Free Report) 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 Stock to Consider

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

A better-ranked stock in the healthcare sector includes Alimera Sciences Inc. (ALIM - Free Report) , 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 37.3% year to date.

 

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