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Gilead gets CHMP nod

Published on 25/11/13 at 07:57am
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Gilead HQ at Stockley Park, London

The CHMP has opened the way for Gilead Sciences’ first-in-class investigational chronic hepatitis C drug Sovaldi (sofosbuvir) to get to market soon, by giving it the thumbs-up.

A key FDA panel has already given its own verdict on the treatment, the first without interferon for hepatitis C, by recommending it for US use.

Its major selling point is that it would remove the need for injectable interferon drugs which can cause debilitating side effects.

The EMA committee suggests Sovaldi should be granted a marketing authorisation in combination with other products to treat chronic hepatitis C in adults, which affects between 0.4% and 3.5% of the population in different EU member states.

Current standard of care includes a combination of pegylated interferon and ribavirin, with or without an inhibitor of the viral NS3/4A protease enzyme.

Other opinions adopted at the CHMP’s November meeting include the approval of ViiV and partner GlaxoSmithKline’s new HIV treatment Tivicay (dolutegravir) in combination with other anti-retroviral medicines.

The FDA led the way on this in August, recommending the integrase inhibitor in conjunction with Ziagen (abacavir) and Zeffix (lamivudine).

The CHMP has also given the green light to two orphan drugs for tuberculosis medicines: the first is Otsuka’s Deltyba (delamanid) for pulmonary infections due to multidrug-resistant tuberculosis.

This is a U-turn from the CHMP, which gave a negative opinion on the drug in July - a decision that the manufacturer asked to be looked at again.

Lucane Pharma’s Para-aminosalicylic acid Lucane has also been recommended to treat multidrug-resistant tuberculosis.

Meanwhile Bristol-Myers Squibb has been given the nod for its type 2 diabetes treatment Xigduo, which combines Forxiga (dapagliflozin) and metformin hydrochloride in a twice-daily tablet.

The Committee gave a positive recommendation for FGK Representative Service’s orphan drug Cholic Acid FGK for the treatment of inborn errors of primary bile acid synthesis.

And Accord Healthcare’s generic medicine Zoledronic Acid Accord received a positive opinion for use in the prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.

The CHMP was not only looking at individual medicines - it also announced the completion of its review of combined hormonal contraceptives (CHCs), endorsing October’s view from the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of CHCs in preventing unwanted pregnancies still outweighed their risks.

Finally, in a blow to Ariad Pharmaceuticals, the CHMP says the use of Ariad’s leukaemia medicine Iclusig (ponatinib) should be restricted to minimise risk of blood clots.

It should not be used in patients who have had a heart attack or stroke in the past, unless the potential benefits to them outweigh the risks, while those with high blood pressure should have it controlled.

Treatment with Iclusig should be stopped immediately in any patient with signs of blood clots obstructing arteries or veins.

Adam Hill

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