Alexion Receives FDA Approval For Label Expansion Of Soliris

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced that the FDA has approved a label expansion of lead drug, Soliris (eculizumab).

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. The FDA approved Soliris following an expedited six-month priority review.

The approval was based on comprehensive results from the phase III randomized, double-blind, placebo-controlled PREVENT study. Patients suffering from NMOSD, who were anti-AQP4 antibody positive, were treated with Soliris or placebo. At 48 weeks, 98% of patients treated with the drug were relapse free compared with 63% with placebo.

The drug is under review for the same in Europe and Japan. Soliris has received Orphan Drug designation (ODD) for the treatment of patients with NMOSD in the United States, the EU and Japan.

We remind investors that the drug is already approved in the United States, the EU, Japan and other countries as a treatment for adult patients with paroxysmal nocturnal hemoglobinuria (PNH), and for adults and children with atypical hemolytic uremic syndrome (aHUS). Soliris is also approved for the treatment of adult patients with generalized MG (gMG) in the United States, the EU and Japan. The underlying growth of the drug has been robust. Label expansion of the drug into additional indications should further boost sales.

Alexion’s share price has rallied 29.5% year to date compared with the industry’s growth of 2.7%.

The approval of long-acting C5 complement inhibitor, Ultomiris, has boosted growth prospects significantly for the company. The drug is approved for PNH in the United States. Moreover, the company is working to expand the drug’s label. The FDA recently accepted Alexion’s supplemental biologics license application (sBLA) for Ultomiris under a priority review for the treatment of patients with aHUS to inhibit complement-mediated thrombotic microangiopathy (TMA). The regulatory body has set an action date of Oct 19, 2019.

Meanwhile, companies like Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) and Akari Therapeutics, Plc (NASDAQ:AKTX) are also developing drugs to address PNH.

Zacks Rank & Key Pick

Alexion currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the same space is Gilead Sciences, Inc. (NASDAQ:GILD) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Gilead’s earnings estimates have moved up by 24 cents to $6.89 for 2019 over the past 90 days.

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