FDA clears AbbVie's hepatitis C regimen Viekira Pak
AbbVie is celebrating after the US FDA approved its all-oral hepatitis C regimen Viekira Pak, which has been tipped by analysts to achieve peak sales of around $3 billion.
The regimen consists of Viekira (ombitasvir/paritaprevir/ritonavir) along with Exviera (dasabuvir) and can be administered with or without ribavirin for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including those with cirrhosis.
US approval for the therapy comes shortly after it was recommended for approval by the EU's Committee for Medicinal Products for Human Use (CHMP) for use in genotypes 1 and 4 HCV.
The FDA notes that Viekira Pak is the fourth drug product approved by the agency in the past year to treat chronic HCV infection after Johnson & Johnson's Olysio (simeprevir) and Gilead Sciences' Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir).
AbbVie is hoping Viekira Pak will emulate the performance of Sovaldi, which benefitted from huge pent-up demand for an HCV regimen that did not include hard-to-tolerate interferon and achieved sales of $8.5 billion during the first nine months of 2014.
AbbVie said it would price Viekira Pak at $83,319 for a 12-week course, which is approximately a 12 per cent discount to Harvoni's $94,500 price tag for the same treatment duration.
PBM drops Sovaldi
The move seems to have struck an immediate chord with pharmacy benefit management (PBM) organisations, with Express Scripts promptly announcing its largest plan will only cover AbbVie's therapy and exclude its rivals, although AbbVie reportedly sweetened the deal by offering the insurer an undisclosed discount.
Express Scripts has been a vocal critic of the high, $84,000 per course, price charged for Sovaldi, which focused attention on the pricing of new medicines and the difficulties faced by healthcare systems paying for new drugs that are clearly much more effective than current therapies.
"The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease," said Howard Cox, the director of the FDA's Office of Antimicrobial Products.
"We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens," he added.
Viekira Pak does require patients to take more tablets per day than its rivals, but this is not seen as a major impediment, given the relatively short course of treatment.
AbbVie has also announced an assistance programme to provide the drug at no charge for patients in financial difficulties and said that, for those with insurance, 'out-of-pocket costs for eligible patients could be as little as $5 per month'.
Viekira Pak's arrival in the market is a major boost for AbbVie, which is trying to expand its product portfolio in order to reduce its 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.
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AbbVie's oral hepatitis C regimen backed for EU approval
