Medicines Co. picks up a pair of FDA approvals amid a regulatory turnaround

The Medicines Company ($MDCO) won FDA approval for a pair of new acute care treatments, moving on from a series of setbacks with hopes of bagging a third nod next month.

The agency signed off on Raplixa, a spray-on sealant designed to stem bleeding during surgery, and Ionsys, a drug-device combo that delivers fentanyl under the skin to treat postoperative pain. Raplixa's nod, coming a month after EU approval, is based on a 721-patient Phase III trial in which the sealant significantly beat out standard sponges in controlling bleeding during surgery, the FDA said.

Ionsys' trip to the market has been a bit more complicated. Originally developed by Johnson & Johnson ($JNJ), the combo system won approval in the U.S. and Europe in 2006, but device stability issues led to a voluntary overseas recall in 2008, and its stateside launch was summarily aborted. A venture-backed California company called Incline Therapeutics later bought the technology to pick up where J&J left off, and the Medicines Co. stepped in to poach Ionsys in a 2012 buyout.

The pair of approvals extend the Medicines Co.'s recent string of success, a welcome change in fortune for a drugmaker long hampered by clinical and regulatory setbacks. Last year, after a 6-year delay, the company won FDA approval for the antibiotic Orbactiv, and the same drug picked up European clearance in March, alongside Raplixa and cangrelor, an anticoagulant rejected by the FDA in 2014.

Now the Medicines Co.'s is hoping to keep its streak going. The company resubmitted cangrelor last year, following the FDA's instructions by reanalyzing some Phase III data and scaling back its desired indication, and a panel of agency advisers voted in favor of approving the intravenous treatment at a meeting last month. Now the FDA is slated to hand down a final decision on cangrelor by June 23.

- read the Raplixa release
- here's the Ionsys statement

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.