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BMS' daclatasvir scuppered by decision to drop companion drug

FDA denies approval due to discontinuation of asunaprevir development
BMS daclatasvir

Bristol-Myers Squibb (BMS) has been blocked from getting US approval for hepatitis C virus (HCV) drug daclatasvir because the drug it was developed alongside has been dropped from development.

The FDA issued a complete response letter for NS5A inhibitor daclatasvir saying it was unable to approve the drug because the marketing application was for its use in tandem with asunaprevir, an NS3/NS4A protease inhibitor discontinued in the US by BMS last month for commercial reasons.

At the time, BMS said that the evolving competitive landscape in HCV therapy - particularly the launch of Gilead Sciences' massive-selling Sovaldi (sofosbuvir) - was behind the decision.

That now looks like a major blunder, with the FDA now asking for additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV as BMS marketing application for daclatasvir focused on its use in use alongside asunaprevir, a regimen that was granted breakthrough status by the FDA back in February.

The extent of the delay to daclatasvir in the US is hard to gauge at this point, with BMS saying in a statement that it "is in discussions with the FDA about the scope of these data".

The net result is that BMS is looking increasingly like an also-ran in the HCV market, with Gilead consolidating its dominant position with the recent approval in the US and EU for Sovaldi follow-up Harvoni (sofosbuvir and NS5A inhibitor ledipasvir) as well as looming competition from AbbVie's new cocktail of Viekirax (ombitasvir, paritaprevir and ritonavir) and Exviera (dasabuvir).

Daclatasvir is already on the market in Europe - where it is sold as Daklinza - and also in Japan where it was approved alongside asunaprevir in July as the country's first all-oral HCV therapy. However, a delay in the large US market is clearly a major setback for BMS' ambitions in hepatitis therapy.

BMS has put a brave face on the disappointment, with chief scientific officer Francis Cuss insisting that the company's "commitment remains to make daclatasvir-based regimens available to help … difficult-to-treat patients achieve cure."

The company says its ongoing trials of daclatasvir are focusing on difficult-to-treat patients, including pre- and post-liver transplant (ALLY-1), HCV patients co-infected with HIV (ALLY-2) and patients with genotype 3 (ALLY-3), a form of the virus generally encountered in Asia.

Meanwhile a series of phase III studies under the UNITY banner are investigating an all-oral fixed-dose-combination of daclatasvir, asunaprevir and NS5B polymerase inhibitor beclabuvir in non-cirrhotic naïve, cirrhotic naïve and previously-treated HCV patients. The triple regimen could be filed for approval next year.

Article by
Phil Taylor

27th November 2014

From: Research, Sales, Regulatory

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