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FDA approves antibacterial skin drug Orbactiv

US regulator authorises Medicines Company's treatment for ABSSSI

US regulator Food and Drug Administrator FDAThe Food and Drug Administration has approved antibacterial drug Orbactiv (oritavancin) to treat adults with acute bacterial skin and skin structure infections (ABSSSI).

Manufactured by The Medicines Company and administered intravenously, Orbactiv is authorised for patients with ABSSSI caused by bacteria such as Staphylococcus aureus (including methicillin-susceptible and -resistant strains), various Streptococcus species and Enterococcus faecalis.

ABSSSI is a catch-all term for a range of infections including cellulitis, cutaneous abscesses and wound infections, which can be life-threatening and may require surgery and hospitalisation. Increasingly, ABSSSIs are associated with drug-resistant pathogens.

There have been worries in the US and Europe over the past decade about the lack of antibiotic drug development, leading to regulatory initiatives - such as the Generating Antibiotic Incentives Now (GAIN) element of the FDA Safety and Innovation Act - aimed at stimulating R&D in this area.

Orbactiv is the third new antibacterial drug approved by the FDA so far in 2014 to treat ABSSSI, following licences for Durata Therapeutics' Dalvance (dalbavancin) and Cubist Pharmaceuticals' Sivextro (tedizolid).

Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said: “The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians.

“However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs.”

Orbactiv was given priority review by the US regulator after being designated as a qualified infectious disease product (QIDP) because it is an antibacterial to treat “a serious or life-threatening infection”.

In two trials of nearly 2,000 adults with ABSSSI, Orbactiv showed itself to be as effective as the common antibiotic vancomycin, with the most common side effects being headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs and diarrhea.

The QIPD designation also means the brand receives an extra five years of marketing exclusivity after the various exclusivity periods it gets under the Food, Drug, and Cosmetic Act.

Article by
Adam Hill

7th August 2014

From: Regulatory



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