FDA Approves Antibacterial Orbactiv Under New Incentive Pathway

The FDA has approved The Medicines Company’s intravenous skin disease treatment Orbactiv, the third such product cleared this year under a pathway that provides manufacturers incentives to develop new antibiotics for serious or life-threatening infections.

Orbactiv (oritavancin) is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), the agency said. The drug was designated a qualified infectious disease product (QIDP) under the 2012 Generating Antibiotic Incentives Now Act, which aims to accelerate new treatments for increasingly resistant infections.

In light of this growing challenge, a single, once-only IV therapy such as Orbactiv offers the option to administer a single treatment in the outpatient setting for patients with skin infections caused by Gram-positive bacteria likely due to MRSA, said Charles Pollack, chair of the department of emergency medicine at Pennsylvania Hospital.

In two clinical trials of 1,987 adults with ABSSSI, many of whom had confirmed cases of MRSA, Orbactiv was as effective as the comparator drug, vancomycin — an antibiotic whose injectable form is generally only given to patients with severe infections, according to the Mayo Clinic.

As part of its QIDP designation, Orbactiv received a priority review and five extra years of marketing exclusivity. Two other products have won approval recently under QIDP: Durata Therapeutics’ Dalvance (dalbavancin) in May and Cubist Pharmaceutical’s Sivextro in June.

The Medicines Company said that it has submitted a marketing authorization application to the European Medicines Agency, which is likely to issue a decision in the first half of next year. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.