Bristol-Myers Squibb Company's Hepatitis C Drug to Lose Special Breakthrough Status From the FDA

Bristol-Myers Squibb Company's Hepatitis C Drug to Lose Special Breakthrough Status From the FDA
February 10, 2015
By Alex Keown, BioSpace.com Breaking News Staff

PRINCETON, N.J. – Bristol-Myers Squibb Company is the second major pharmaceutical company within a week to lose its breakthrough drug designation for a planned hepatitis C medication.

The U.S. Food and Drug Administration (FDA) granted the breakthrough drug status to Bristol Myer’s daclatasvir last year for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV). In November though, the FDA requested additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV after the withdrawal of asunaprevir as a combination medicine. The company said it would continue to seek U.S. approval for daclatasvir in combination with other therapies. Daclatasvir is currently marketed as Daklinza in Japan and the European Union.

Last week the FDA announced it might recind breakthrough status from Merck & Co. for grazoprevir/elbasvir, the company’s investigational oral, once-daily combination regimen for the treatment of chronic HCV infection. It consists of a protease inhibitor called MK-5172 and a so-called NS5A inhibitor called MK-8742 that together had received the "breakthrough therapy" designation from the FDA.

"As a result, Merck intends to discuss this matter with the FDA in the coming weeks," a spokesperson for Merck told BioSpace. "During this meeting, Merck will have the opportunity to provide additional information which will help the agency determine the criteria for breakthrough designation to continue to be met."

According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

HCV is the most common chronic blood infection in the country, with approximately 3.2 million cases. According to the U.S Center for Disease Control HCV, which causes damage to the liver, is most efficiently transmitted through large or repeated percutaneous exposure to infected blood.

If approved, Daclatasvir would have stiff competition in the HCV treatment market. Daclatasvir will compete against therapies from Gilead Sciences, Inc. and AbbVie Oral treatments from Gilead Sciences, Inc. (GILD) and Abbvie have wiped out all signs of the virus in more than 90 percent of patients after eight or 12 weeks, according to a company data.

Gilead reported selling $10.3 billion of its new hepatitis C drug Sovaldi in 2014, at approximately $1,000 per pill. Harvoni, another HCV medication produced by Gilead sold about $2.1 billion in 2014. AbbVie’s HCV medication Humira recorded $12.5 billion in sales. In December AbbVie introduced a new hepatitis C treatment called Viekira Pak.

Despite the competition, Bristol Myers says it is committed to the hepatitis C market, seeking to use daclatasvir in combinations with other compounds to target difficult to treat patients, such as HIV co-infected patients and those with genotype 3.

“Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area,” Francis Cuss , Bristol Myers’ chief scientific officer, said in a press release. “Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the U.S. as quickly as possible.”

 

 


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