AbbVie’s oral hepatitis C regimen backed for EU approval

AbbVie has closed in on the first approval of its four-drug hepatitis C virus regimen, after the EU’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the therapy.

The CHMP gave a green light to the oral, interferon-free regimen – based on Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir) – for patients with genotype 1 or genotype 4 HCV infections.  It can be given with or without ribavirin.

Viekirax combines a fixed-dose combination of the NS3/4A protease inhibitor paritaprevir and ritonavir – which boosts levels of its partner drug – with the NS5A inhibitor ombitasvir, while the active ingredient in Exviera acts as a non-nucleoside NS5B polymerase inhibitor. A final decision on approval by the European Commission is expected in the first quarter of 2015, said AbbVie.

Viekirax and Exviera are the fourth new HCV therapy to be granted positive opinions in the EU within the last 12 months, joining Gilead Sciences’ Sovaldi (sofosbuvir) and dual therapy Harvoni (sofosbuvir and ledipasvir) as well as Bristol-Myers Squibb’s Daklinza (daclatasvir).

Such was the pent-up demand for these new oral regimens – which do away with the need for HCV patients to receive hard-to-tolerate interferon injections – that Sovaldi racked up a record-breaking $8.5 billion in sales in its first nine months on the market.

AbbVie’s entrant is not expected to reach those dizzy heights given the increased competition in the sector. However, it has been predicted to reach an annual turnover of $3 billion or more at peak, which would go a long way towards reducing the company’s reliance on inflammatory disease blockbuster Humira (adalimumab).

Humira had sales of $11.5 billion last year and currently accounts for almost two-thirds of AbbVie’s revenues, but is due to lose patent protection in 2016. Meanwhile, the company’s need to bring new therapies through to market was further highlighted after a proposed $55 billion merger with Shire was abandoned last month thanks to changes to the tax regulations in the US.

The marketing application for Viekirax and Exviera was reviewed under an accelerated assessment by the CHMP and is backed by six phase III studies, including more than 2,300 genotype 1 patients.

The application also included mid-stage data in genotype 4 patients without cirrhosis, as well as preliminary findings in genotype 1 HCV and HIV-1 co-infected patients and liver transplant recipients with recurrent genotype 1 HCV infection who were new to treatment after transplantation.

Viekirax and Exviera have also been granted a priority review in the US and a verdict by the Food and Drug Administration (FDA) is expected by the end of the year.

The approval is also a boost for US company Enanta Pharmaceuticals, which originally discovered paritepravir.

Link

Gilead once-daily hep C drug approved in Europe

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