EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s hu­man med­i­cines com­mit­tee on Fri­day rec­om­mend­ed three new drugs for ap­proval or con­di­tion­al ap­proval, even as their US coun­ter­parts have re­ject­ed these three for var­i­ous rea­sons.

In a ma­jor move, CHMP of­fered a thumbs-up to a con­di­tion­al mar­ket­ing au­tho­riza­tion for the first gene ther­a­py to treat se­vere he­mo­phil­ia A, al­though the agency cau­tioned that it’s so far un­known how long the ef­fects of in­fu­sion will last.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER