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EMA backs drugs from Novo, Otsuka, AZ, Janssen, GSK

Nine new branded medicines recommended for use in Europe
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European regulators have recommended nine new branded drugs for approval in the latest set of positives opinions from the Committee for Medicinal Products for Human Use (CHMP).

Novo Nordisk's haemophilia drug
Among the drugs backed by the CHMP, which provides guidance to the European Medicines Agency (EMA), was Novo Nordisk's NovoEight (turoctocog alfa) for use in the treatment of haemophilia A.

Normally associated with diabetes medicines, Novo has built a burgeoning business in the area of bleeding disorders, led by NovoSeven, which made $1.4bn in revenues in 2012.

The company has expanded its footprint in the area recently with NovoThirteen, which last year received a recommendation for use in the long-term prevention of bleeding in adults and children aged six and over with the inherited blood-clotting condition congenital factor-XIII-A-subunit deficiency.

Novo is now on course to expand its presence in the market even further due to the CHMP's recommendation for use of NovoEight for the treatment and prophylaxis of bleeding in patients with haemophilia A, which causes problems with blood clotting due to the lack of coagulation Factor VIII.

The company said it expects to launch the drug in Europe in early 2014, where it will compete with established products, such as Baxter's Advate, Bayer's Kogenate and Pfizer's ReFacto. NovoEight has also been filed for approval in the US, Japan, Australia and Switzerland.

Backing for AZ's four-strain flu vaccine
AstraZeneca (AZ) won CHMP backing for Fluenz Tetra, a four-strain influenza vaccine administered as a nasal spray.

The recommendation covers the vaccine's use in for the prevention of seasonal influenza in eligible children and adolescents 24 months to 17.

It is intended as a replacement for the company's Fluenz vaccine, which only provides protection against three strains of influenza. It is already available in the US under the name FluMist Quadrivalent.

The decision to go for a vaccine that provides protection against four strains follows similar efforts from GSK and Sanofi.

Janssen's Invokana recommended in diabetes
Type 2 diabetes patients in Europe are set to have access to another treatment to improve glycaemic control after the CHMP recommended Janssen's Invokana (canagliflozin).

The recommendation says that Invokana should be available as a monotherapy for adults with type 2 diabetes if the patient is unable to take metformin, and as an add-on therapy if other glucose-lowering medicinal products including insulin do not provide adequate glycaemic control.

The drug is the second sodium-glucose co-transporter 2 (SGLT2) inhibitor recommend by the CHMP after Forxiga from AZ/ Bristol-Myers Squibb (dapagliflozin).

This type of diabetes drug works by blocking the re-absorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels in diabetics who have elevated blood glucose levels.

Recommendations for Otsuka, Plethora, GSK and Gilead
Other new medicines recommended by the CHMP include Gilead Sciences' Vitekta (elvitegravir) for use in the treatment of adults with HIV.

The drug is part of the Gilead's four-in-one combination HIV therapy Stribild, which was approved in Europe earlier this year.

Otsuka also received good news, winning CHMP backing for schizophrenia treatment Abilify Maintena (aripiprazole).

The medicine is an extended release injectable version of Abilify, which is marketed by Otsuka as part of a collaboration with Lundbeck.

Elsewhere, GSK followed up approval in Japan for its respiratory medicine Relvar Ellipta with a CHMP recommendation for use in asthma and COPD, while Plethora Solution's Lidocaine/ Prilocaine Plethora was backed for the treatment of primary premature ejaculation in adult men

Cancer drugs also recommended
Finally, the CHMP backed two major new cancer drugs – Roche's Kadcyla for the treatment of metastatic breast cancer and and Bayer's Xofigo for the treatment of castration-resistant prostate cancer.

Article by
Thomas Meek

23rd September 2013

From: Sales, Regulatory

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