Alexion Gets Approval For Label Expansion Of Soliris In Japan

Alexion Pharmaceuticals Inc.’s (NASDAQ:ALXN) Soliris received Japan’s Ministry of Health, Labour and Welfare’s (MHLW) approval for a label expansion. The drug is now approved for neuromyelitis optica spectrum disorder (NMOSD) in adult patients, who are anti-aquaporin-4 (AQP4) antibody positive. Soliris is the first and only approved medication for this indication in Japan.

Alexion’s share price has rallied 14% year to date compared with the industry's growth of 2.2%.

The approval was based on comprehensive results from the phase III, randomized, double-blind, placebo-controlled PREVENT study. Patients suffering from NMOSD with anti-AQP4 antibody positive were treated with Soliris or placebo. The study met its primary endpoint of prolonging the time to first adjudicated relapse and reducing the risk of relapse. At 48 weeks, 98% of patients treated with the drug were relapse free compared with 63% with placebo.

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 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.

Soliris was approved for the treatment of NMOSD in adult patients, who are anti-AQP4 antibody-positive, by the FDA in June 2019 and the European Commission (EC) in August. The drug received Orphan Drug designation for the same in the United States, the EU and Japan.

Zacks Rank & Other Key Picks

Alexion currently carries a Zacks Rank #2 (Buy).

A few other top-ranked stocks in the biotech sector are Alkermes Plc. (NASDAQ:ALKS) , Anika Therapeutics Inc. (NASDAQ:ANIK) and and Innoviva Inc. (NASDAQ:INVA) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.

Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.36 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.

Innoviva’s earnings per share estimates have gone up from $1.59 to $2.03 for 2019 and from $1.22 to $1.34 for 2020 in the past 60 days.

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