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Alexion Wins EC Nod for Soliris in Nervous System Disorder
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Alexion Pharmaceuticals, Inc. announced that the European Commission (EC) has approved the label expansion of lead drug, Soliris.
The drug is now approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients, who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.
The EC approval was based on comprehensive results from the phase III randomized, double-blind, placebo-controlled PREVENT study and a long-term extension study (ECU-NMO-302), which is still underway. The study met its primary endpoint of prolonging the time to first adjudicated relapse and reducing the risk of relapse. Per the data, 98% of adult AQP4 antibody-positive patients treated with Soliris were relapse free compared to 63% receiving placebo at 48 weeks. The encouraging results demonstrated the potential of Soliris to change the treatment paradigm for this rare, devastating, complement-mediated disorder of the central nervous system.
We remind investors that the FDA has already approved the drug for the treatment of NMOSD in adult patients, who are AQP4 antibody-positive, in June 2019. A supplemental New Drug Application is currently under review by regulatory authorities in Japan. The drug enjoys an Orphan Drug designation (ODD) for the treatment of NMOSD in the United States, the EU and Japan.
Soliris, a first-in-class complement inhibitor that inhibits the C5 protein, is already approved for the treatment of two severe and ultra-rare disorders— paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome — in the United States and Europe. The FDA has also approved the drug for the indication of the generalized myasthenia gravis.
The label expansion of the drug should further boost sales. The FDA recently approved Alexion’s long-acting C5 complement inhibitor, Ultomiris, for the treatment of adults with PNH. This consolidated the company’s PNH franchise. It plans to evaluate the drug for the NMOSD indication as well.
Shares of the company have gained 13.2% in the year so far against the industry’s decline of 2.3%.
We note that Alexion was recently in the news on speculations of a potential buyout by biotech bigwig Amgen (AMGN - Free Report) . However, Amgen recently announced an agreement to acquire Celgene Corporation’s plaque psoriasis and psoriatic arthritis drug, Otezla, for more than $13.4 billion, thereby squashing the speculations of buying out Alexion. Alexion’s stock declined on the news. Nevertheless, the company has been one of the prime candidates for acquisition from the onset of 2019 after the mega-merger announcement of Bristol-Myers (BMY - Free Report) and Celgene.
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Alexion Wins EC Nod for Soliris in Nervous System Disorder
Alexion Pharmaceuticals, Inc. announced that the European Commission (EC) has approved the label expansion of lead drug, Soliris.
The drug is now approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients, who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.
The EC approval was based on comprehensive results from the phase III randomized, double-blind, placebo-controlled PREVENT study and a long-term extension study (ECU-NMO-302), which is still underway. The study met its primary endpoint of prolonging the time to first adjudicated relapse and reducing the risk of relapse. Per the data, 98% of adult AQP4 antibody-positive patients treated with Soliris were relapse free compared to 63% receiving placebo at 48 weeks. The encouraging results demonstrated the potential of Soliris to change the treatment paradigm for this rare, devastating, complement-mediated disorder of the central nervous system.
We remind investors that the FDA has already approved the drug for the treatment of NMOSD in adult patients, who are AQP4 antibody-positive, in June 2019. A supplemental New Drug Application is currently under review by regulatory authorities in Japan. The drug enjoys an Orphan Drug designation (ODD) for the treatment of NMOSD in the United States, the EU and Japan.
Soliris, a first-in-class complement inhibitor that inhibits the C5 protein, is already approved for the treatment of two severe and ultra-rare disorders— paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome — in the United States and Europe. The FDA has also approved the drug for the indication of the generalized myasthenia gravis.
The label expansion of the drug should further boost sales. The FDA recently approved Alexion’s long-acting C5 complement inhibitor, Ultomiris, for the treatment of adults with PNH. This consolidated the company’s PNH franchise. It plans to evaluate the drug for the NMOSD indication as well.
Shares of the company have gained 13.2% in the year so far against the industry’s decline of 2.3%.
We note that Alexion was recently in the news on speculations of a potential buyout by biotech bigwig Amgen (AMGN - Free Report) . However, Amgen recently announced an agreement to acquire Celgene Corporation’s plaque psoriasis and psoriatic arthritis drug, Otezla, for more than $13.4 billion, thereby squashing the speculations of buying out Alexion. Alexion’s stock declined on the news. Nevertheless, the company has been one of the prime candidates for acquisition from the onset of 2019 after the mega-merger announcement of Bristol-Myers (BMY - Free Report) and Celgene.
Alexion currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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