July 3, 2018
Bioscience Notebook

Alexion seeks European approval for Soliris successor

Photo | Contributed
Photo | Contributed
Alexion Pharmaceuticals' New Haven headquarters.
Photo | Contributed
Biohaven CEO Dr. Vlad Coric.

New Haven-headquartered Alexion Pharmaceuticals Inc., which last month filed for U.S. approval of its Soliris successor drug ALXN1210, is now setting its sights on Europe.

Alexion last week submitted an application with the European Medicines Agency, the European equivalent of the U.S. Food and Drug Administration, for ALXN1210 to treat the rare blood disease PNH (paroxysmal nocturnal hemoglobinuria.)

The move follows results of a Phase 3 study that found the drug on par with Alexion's blockbuster and chief money-maker, Soliris, for patients with PNH. Patients can safely switch from Soliris every two weeks to the new drug every eight weeks, the study found.

"We are excited about this next important step toward our goal of establishing ALXN1210 as the new standard of care for patients with PNH, following our recent submission in the U.S.," said Dr. John Orloff, Alexion's executive vice president and head of research and development.

Alexion plans to seek approval in Japan later this year.

In other news, Biohaven Pharmaceutical Holding Co. Ltd. of New Haven said it will launch a Phase 3 clinical trial by the end of this year to find out if its cutting-edge migraine drug can prevent an attack as well as stop one in progress.

Biohaven earlier this year announced the results of Phase 3 studies that found the drug, rimegepant, was better than a placebo at relieving pain and other symptoms during an attack, such as light sensitivity and nausea.

Proving the drug's potential to prevent migraines "will be important to further characterizing its utility in migraine and differentiating from competitor products," said Biohaven CEO Dr. Vlad Coric.

Rimegepant is part of a potential new class of drugs known as calcitonin gene-related peptide (CGRP) receptor antagonists, which stop migraines by blocking a brain chemical that transmits pain.

They are being targeted to migraine sufferers with heart conditions, who are unable to take the popular migraine drug Imitrex and others like it because they constrict blood vessels.

Also last week, Branford-based BioXcel announced positive results from an early clinical trial of a drug to calm agitation in dementia patients.

The company, which uses artificial intelligence to develop new drugs and repurpose older ones, said the IV version of dexmedetomidine (Dex) met the goal of achieving mild sedation without affecting the heart.

Dex is an older, FDA-approved injectable drug that BioXcel is reformulating for use in dementia patients. The company said it will use results from the Phase 1b study to develop its "sublingual," or under-the-tongue version, BXCL501.

The drug had a sedating effect on 11 of 12 healthy volunteer subjects in the study, compared to only one in four taking a placebo, and the sedation lasted up to two hours, the study found.

BioXcel said it will next test the drug on dementia patients.

Reach Natalie Missakian at news@newhavenbiz.com

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