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Antibiotics among 7 new drugs backed by EMA

The Medicines Company’s Orbactiv and Cubist’s Sivextro set for European approval
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The pressing public health challenge of antimicrobial resistance was given a boost today with two new antibiotics recommended for European approval.

Both The Medicines Company's Orbactiv (oritavancin) and Cubist's Sivextro (tedizolid phosphate) were among seven new medicines backed by EMA scientific advisers in the Committee for Medicinal Products for Human Use (CHMP).

Both drugs are recommended in the same indication: the treatment of acute bacterial skin and skin structure infections (ABSSSI). Orbactiv and Sivextro are already recommended by the US FDA to treat these forms of infections.

The recommendation is good news for the EU, which like the rest of the world is waking up to the threat of infectious diseases becoming resistant to existing antibiotics.

Cubist and The Medicines Company are two of the few pharma firms still dedicated to researching new drugs in the area, where industry investments have declined in the past couple of decades due, in part, to the poor return on investment offered by products.

However, the growing need for new drugs has perked up interest in developing new antibiotics with Cubit's promising pipeline attracting Merck & Co, which agreed to acquire the company last year.

Other recommendations

The Medicines Company had a second new drug feature among the list of CHMP positive opinions. Kengrexal (cangrelor) was recommended for use in the reduction of thrombotic cardiovascular events in adults with coronary artery disease.

Elsewhere there was a recommendation for a new drug to support weight loss in the form of Novo Nordisk's Saxenda (liraglutide). The active ingredient is already available in the diabetes treatment Victoza.

Other new drugs backed by the CHMP include Merck & Co's Dutrebis (lamivudine/raltegravir), another addition to the growing list of combination regimens for HIV.

The final two drugs to feature in the list of positive opinions were Santen's Ikervis (ciclosporin) for the treatment of the eye condition severe keratitis and MDCO's Raplixa (human fibrinogen / human thrombin) as a supportive treatment for the bleeding disorder haemostasis.

Article by
Thomas Meek

23rd January 2015

From: Sales, Regulatory



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