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Alexion (ALXN) Submits Application for ALXN1210 with FDA

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Alexion Pharmaceuticals, Inc. (ALXN - Free Report) ) submitted a Biologics License Application (BLA) to the FDA for approval of ALXN1210, the company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).

The company uses a rare disease priority review voucher, which enables the FDA to expedite the review in eight months, instead of the standard 12 months. Priority Review designation from the FDA is generally granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. 

The application is supported by data from two rigorous phase III studies in the largest population of patients with PNH ever studied The studies included patients who had never received a complement inhibitor, and patients who were stable on Alexion’s lead drugSoliris (eculizumab) and switched to ALXN1210. 

The objective of the studies was to demonstrate that patients with PNH can be effectively and safely switched from treatment with Soliris, every two weeks, to treatment with ALXN1210, every eight weeks. Weight-optimized treatment with ALXN1210, every eight weeks, demonstrated non-inferiority to treatment every two weeks with Soliris on all primary endpoints and key secondary endpoints, in both studies.

Moreover, none of the patients, treated with ALXN1210, experienced breakthrough hemolysis (one of the key secondary endpoints) compared to five patients treated with Soliris.

In addition to the BLA in the United States, Alexion is preparing submissions for the approval of ALXN1210 as a treatment for patients with PNH in the European Union (EU) by mid-year and in Japan in the second half of the year.

Year to date, shares of Alexion have increased 2% against the industry’s decline of 5.8%.

 

Further, Alexion is enrolling pediatric PNH patients in a phase III study of ALXN1210. The study includes patients who have never received treatment with a complement inhibitor and those who enter the study stabilized on Soliris. Patients are also being enrolled and dosed in a phase III trial, with ALXN1210 administered intravenously, every eight weeks, in complement inhibitor treatment-naive adolescent and adult patients with atypical hemolytic uremic syndrome (aHUS). 

The company is expected to complete enrollment in the second quarter and announce the results in the fourth quarter of 2018. Enrollment and dosing are also ongoing in a phase III trial of ALXN1210 in pediatric patients with aHUS.

 

Zacks Rank & Stocks to Consider

Alexion has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Illumina, Inc. (ILMN - Free Report) , Aeglea BioTherapeutics, Inc. (AGLE - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . While Illumina sports a Zacks Rank#1 (Strong Buy), Aeglea and ANI Pharmaceuticals carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings per share estimates have moved up from $4.60 to $4.86 for 2018 and from $5.34 to $5.61 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 23.17%. The stock has rallied 30.8% so far this year.

Aeglea’s loss per share estimates have narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 99.6% so far this year.

ANI Pharmaceuticals’earnings per share estimates have moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 4.3% so far this year.

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