Friday, June 20, 2014

Boehringer Ingelheim exits hepatitis C field, pulls regulatory filings for faldaprevir

Boehringer Ingelheim exits hepatitis C field, pulls regulatory filings for faldaprevir
By: Joe Barber
Boehringer Ingelheim on Friday announced that following a strategic review the company has decided against moving forward in the field of hepatitis C. As such, the drugmaker indicated that it will withdraw all regulatory filings for faldaprevir, which had been granted accelerated assessment by the European Medicines Agency, and will discontinue further development of the protease inhibitor.

The company noted that "the HCV treatment environment has significantly and rapidly evolved" since filing faldaprevir, adding "there are now several new treatment options available for patients and additional all-oral options are expected to be approved in 2014." Boehringer Ingelheim added that as a result, an unmet medical need no longer exists for the faldaprevir interferon-based regimen that was the subject of the regulatory filings.

In February, Gilead Sciences submitted its all-oral hepatitis C treatment combination of the nucleotide analogue polymerase inhibitor Sovaldi (sofosbuvir), which was cleared in the US in December and in Europe earlier this year, and the NS5A inhibitor ledipasvir for FDA approval. Meanwhile, the FDA recently granted priority review to AbbVie's interferon-free regimen of the protease inhibitor ABT-450 boosted by ritonavir and co-formulated with the polymerase inhibitor dasabuvir and the NS5A inhibitor ombitasvir. In addition, Johnson & Johnson has applied for FDA marketing authorisation for the NS3/4A protease inhibitor Olysio (simeprevir), which was approved in the US last year and in Europe in May, in combination with Sovaldi. Earlier this year, Bristol-Myers Squibb's all-oral regimen of the NS5A replication complex inhibitor daclatasvir and the NS3 protease inhibitor asunaprevir attained FDA breakthrough therapy status.

Boehringer Ingelheim indicated that it remains committed to developing new treatment options and will focus its efforts on the development of drugs for immunology, cardiovascular, respiratory, and metabolic diseases, central nervous system disorders and oncology.

For related analysis, see ViewPoints: Competitor dynamics shift in hepatitis C market. For more information on the hepatitis C market, see Hepatitis C: KOL Insight and Consensus Outlook.

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