Amgen sees romiplostim review extended

Amgen has been notified by the Food and Drug Administration (FDA) that the date for its priority review of the company’s Biologics License Agreement application for romiplostim has been moved back to July 23rd.

The move comes after Amgen submitted a new risk management programme for the drug, which the FDA considers a “major amendment”. This automatically triggered a three-month review extension under the Prescription Drug Users Fee Act (PDUFA).

Romiplostim is a treatment for thrombocytopenia in adults suffering with chronic immune thrombocytopenic purpura, or ITP.

In March, the Oncologic Drugs Advisory Committee (ODAC) unanimously voted in favour of recommending romiplostim for the treatment of ITP and Amgen believes further discussions with the FDA will prove “productive”.

A statement from the company said: “Amgen believes the data contained in our registrational clinical studies paired with our proposed comprehensive risk management program, together support approval by the FDA, [provides] ITP patients with a potential new treatment option.”

Amgen is a Fortune 500 company that works to discover, develop and manufacturer new therapies.

It launched the first biotechnology “blockbuster” medicines and pioneered the development of products based on advances in recombinant DNA and molecular biology.