Bristol-Myers Hepatitis C Drug to Lose Special Status From FDA

Bristol-Myers Squibb Co. said a hepatitis C drug will lose a special designation from U.S. regulators that may have led to faster market approval.

Merck & Co., the second-biggest U.S. drugmaker, said Feb. 4 that the Food and Drug Administration was planning to rescind the same status for one of its experimental hepatitis C therapies, citing the availability of other approved drugs.

Hepatitis C treatment has been transformed in recent years as Gilead Sciences Inc. and AbbVie Inc. gained approval for more convenient medications that can cure the disease in as little as eight weeks with fewer side effects than older therapies. The drugs come with hefty price tags that have drawn criticism -- for example, Gilead’s Harvoni costs $94,500 for a 12-week course of treatment.

About 3.2 million people in the U.S. have hepatitis C, a viral infection that damages the liver and can lead to a transplant, according to the U.S. Centers for Disease Control and Prevention. As many as 250,000 patients in the U.S. may be treated with hepatitis C drugs this year, Gilead has said.

The FDA program, called “breakthrough designation,” allows drugmakers to work closely with the agency to get experimental treatments submitted faster for regulatory review. Breakthrough designations are given to new therapies that represent a significant medical advance.

The designation will no longer apply to hepatitis C regimens that involve Bristol-Myers’s daclatasvir for genotype 1, the most common type of the disease in the U.S., the company said in a statement.

Market Competition

Bristol-Myers has been developing daclatasvir as part of its program for treating hepatitis C. With the new drugs from Gilead and AbbVie on the market and Merck’s medicine awaiting approval, New York-based Bristol-Myers isn’t expected to gain significant market share in the short term.

Bristol-Myers also gave up seeking U.S. market clearance for a combination medicine of daclatasvir and asunaprevir in October, citing the “rapidly evolving hepatitis C treatment landscape in the U.S.” The combination was approved in Japan in July. Bristol-Myers said it would continue to seek U.S. approval for daclatasvir in combination with other therapies.

Despite the stiff competition, Bristol-Myers has said it’s 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.

Stephanie Yao, an FDA spokeswoman, declined to comment on the matter.

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