Production & Manufacturing
Process & Production

Bayer submits BLA to FDA for BAY94-9027 to treat Hemophilia A

PBR Staff Writer Published 01 September 2017

Bayer is seeking approval from the US Food and Drug Administration (FDA) for its its long-acting factor VIII, BAY94-9027, to treat Hemophilia A.

The company has submitted biologics license application (BLA) with to the FDA for its long-acting site-specifically PEGylated recombinant human factor VIII to treat Hemophilia A.

BAY94-9027 has been developed to prolong activity in the body, while preserving full coagulation activity through PEGylation, where Polyethylenglycol PEG molecule is systematically attached to the factor VIII protein at a specific site.

PEGylation technology is used to prolong the time of drug circulation in the blood.

Bayer has submitted BLA based on the results of Protect VIII trial, which demonstrated protection from bleeds with dosing intervals when used prophylactically once every seven days, once every five days, and twice per week.

According to the company, the BAY94-9027 was also effective for control of bleeding during surgical procedures and treatment of all bleeds.

Bayer pharmaceutical division executive committee member and development head Dr Joerg Moeller said: “Since introducing Kogenate around 25 years ago, Bayer has been committed to continuously improving disease management for people living with Hemophilia A.

“The filing of BAY94-9027 brings us one step closer to providing a therapeutic option with additional benefits for patients who decided to have a more active lifestyle.”

In May, Bayer received priority review designation from the FDA for its investigational anti-cancer compound copanlisib to treat follicular lymphoma (FL).

The priority review has been specifically designated for treatment of FL patients whose disease had relapsed or is in the refractory stage and had also received at least two therapies before.

Image: Headquarters of Bayer’s pharmaceuticals division in Berlin, Germany. Photo: courtesy of Bayer AG.