Gilead Hepatitis C Pill Leads 27 New U.S. Drug Approvals

Gilead Sciences Lab
An automated machine works on purification of potential hepatitis C virus drug candidate at the Gilead Sciences Inc. lab in Foster City, California. Photographer: David Paul Morris/Bloomberg

Gilead Sciences Inc.’s hepatitis C pill Sovaldi led 27 new U.S. drug approvals in 2013, a “breakthrough” therapy being chased by competitors this year.

Gilead’s pill, designed to cut treatment time by about half, was approved under the Food and Drug Administration’s new program that prioritizes reviews of promising medicines. Johnson & Johnson and Pharmacyclics Inc.’s Imbruvica for blood cancer, as well as Roche Holding AG’s Gazyva for chronic lymphocytic leukemia, also gained approval under the new designation.

All told, the FDA cleared 12 fewer novel drugs in 2013 than the year before, though the rate was in line with historical averages, according to agency data. Despite the drop, last year’s approvals reflect increased effort by the FDA to give pharmaceutical companies better access to agency workers who can shepherd products through reviews, said Michael Yee, an analyst with RBC Capital Markets in San Francisco.

“That makes Wall Street generally feel good, that the FDA pendulum is swinging more in terms of accommodation,” Yee said in an interview. “That doesn’t mean FDA has lowered the hurdle. The FDA is being more collaborative, more accommodating, rather than being an antagonist.”

Sovaldi was the biggest approval of 2013 and is projected to generate $2.5 billion in revenue this year for Foster City, California-based Gilead. Biogen Idec Inc., the Weston, Massachusetts-based maker of multiple sclerosis drugs Avonex and Tysabri, also won clearance for the company’s first pill to treat the disease that is expected to dominate the MS market.

Weight Loss

Hepatitis C treatments are expected to take another leap this year as Gilead, J&J, AbbVie Inc. and Bristol-Myers Squibb Co. vie to market new drugs that eliminate the need for interferon shots, the current standard of treatment. New Brunswick, New Jersey-based J&J and its partner Medivir AB won approval in November for their hepatitis C drug Olysio.

In addition to hepatitis C treatments, a weight-loss pill is awaiting approval in 2014 from Orexigen Therapeutics Inc. and Takeda Pharmaceutical Co. The drug known as Contrave would follow clearances of obesity products from Vivus Inc. and Arena Pharmaceuticals Inc. in 2012, which at the time were the first such medicines approved for sale in the U.S. in 13 years.

Diabetes therapies will also get a turn in the spotlight with the second and third in a new class of treatments from Bristol-Myers and AstraZeneca Plc, and Eli Lilly & Co. and Boehringer Ingelheim GmbH up for approval. J&J won clearance in March for the first in the new family of drugs called Invokana for Type 2 diabetes that expel sugar in the urine after the kidneys filter it through the blood.

Approval Times

As of Dec. 20, the agency received 135 breakthrough designation requests since the program was included in the passage of legislation in July 2012 to reauthorize industry fees that help cover FDA reviews. Thirty-seven breakthrough requests have been granted and 70 denied.

Roche’s Gazyva in November became the first breakthrough approval, to treat chronic lymphocytic leukemia, a blood and bone marrow disease. Less than two weeks later, the agency approved J&J and Pharmacyclics’s Imbruvica to treat mantle cell lymphoma.

The FDA’s help ushering Imbruvica to market shaved as much as a year off the approval time, Urte Gayko, senior vice president of regulatory at Sunnyvale, California-based Pharmacyclics, said in an interview.

With the agency’s recognition that early research showed promise, the companies were able to file an application for FDA review nine months ahead of schedule relying only on one mid-stage clinical trial, Gayko said. In addition, the agency finished reviewing the application and approved Imbruvica Nov. 13, a few months early.

‘Intense Review’

“It was a very intense review process,” Gayko said. “Even though they made us work over many weekends, it was a good collaborative effort. We have been very pleased.”

In 2012 targeted cancer therapies received most of the attention, pushing drug approvals to 39, the highest level in 15 years. Approvals of innovative medicines have averaged about 23 a year over a decade and 28 over the past five years.

Approvals fell in 2013 partly because of a drop in applications. The agency received 32 requests for clearance as of Dec. 11, down from 41 in 2012.

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