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BMS follows Merck as glut of HCV drugs leads to loss of fast-track status

Dan Stanton

By Dan Stanton+

11-Feb-2015
Last updated on 11-Feb-2015 at 11:23 GMT2015-02-11T11:23:42Z

Options aplenty for HCV sufferers, thus US FDA rescinds a second breakthrough designation
Options aplenty for HCV sufferers, thus US FDA rescinds a second breakthrough designation

The US FDA has rescinded Breakthrough Therapy designation of a second HCV treatment, but Bristol-Myers Squibb says submission timelines for daclatasvir will not be affected.

Approvals for Gilead, Janssen and - most recently - AbbVie mean there are now four treatment options available for the estimated 3.2 million people in the US living with chronic Hepatitis C virus infection.

Therefore the need to fast-track development and approval of other HCV treatments has become redundant, and the US Food and Drug Administration (FDA) has withdrawn a Bristol-Myers Squibb candidate from its Breakthrough Therapy designation, days after rescinding the status of Merck & Co.’s grazoprevir/elbasvir combination pill.

“The FDA has informed Bristol-Myers Squibb that, due to the evolving HCV treatment landscape, the agency intends to rescind the Breakthrough Therapy Designation for certain genotype 1 Hepatitis C regimens,” BMS spokesman Rob Perry said.

However, he told in-Pharmatechnologist.com the loss of status will not impact the current submission/resubmission timetable of the new drug application for daclatasvir in combination with other antiviral agents for the treatment of Hepatitis C.

The criteria for breakthrough designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Such status had been issued to both BMS’s daclatasvir/asunaprevir combination, and a triple all-oral regimen containing daclatasvir, asunaprevir and the compound BMS-791325, both of which are covered by the FDA’s plan to rescind.

BMS announced in October it was not planning to pursue approval of the dual regimen in the US due to “the rapidly evolving hepatitis C treatment landscape,” but Perry said it continued to investigate daclatasvir in combination with other antiviral agents for both the US and other markets.

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