Drug Approvals

Celgene wins key FDA ok ahead of BMS merger

Aug 19, 2019

The U.S. FDA has approved Celgene's rare bone marrow cancer drug, Inrebic, giving the drugmaker a big regulatory win ahead of its proposed merger with Bristol-Myers Squibb.

Inrebic, a treatment for myelofibrosis, is one of suite of five drugs that Bristol-Myers Squibb regarded as valuable in its deal to buy Celgene. The drug is only the second drug cleared in the U.S. to treat myelofibrosis. Inrebic will carry a black box warning for serious and fatal encephalopathy, including Wernicke’s, a life-threatening neurological condition.

In April, Bristol-Myers Squibb shareholders approved the company’s $74 billion acquisition of rival Celgene, despite activist campaigns to break up the deal.

Read the press release