FDA supports new Hepatitis C drug from Vertex Pharmaceuticals

By Dr. Ananya Mandal, MDApr 26 2011

Vertex Pharmaceuticals jumped 10 percent in value on the Nasdaq after U.S. regulators FDA said the company’s experimental hepatitis C drug cures more patients than current therapies.

The Food and Drug Administration staff said in a preliminary review on the agency’s website that Telaprevir, combined with standard treatments, was more effective than those drugs alone in clinical trials. Outside advisers to the FDA are scheduled to meet April 28 to weigh the drug’s benefits and risks.

Meanwhile Vertex and Merck & Co are racing to win FDA clearance of a drug for the blood borne liver disease – hepatitis C. Merck, of Whitehouse Station, New Jersey, and Cambridge, Massachusetts-based Vertex are among about a dozen companies seeking to offer hepatitis C drugs with better results and fewer side effects than standard therapy.

FDA staff said, “Overall, the FDA review team’s independent analyses confirmed the applicant’s primary efficacy findings and many secondary endpoint analyses for all pivotal clinical trials.” Vertex’s drug increases risks of skin rashes and anemia, they added.

Vertex rose $4.88 to $52.92 at 4 p.m. New York time, the biggest gain since Feb. 23. Merck advanced 2.1 percent to $35.06 in New York Stock Exchange composite trading.

Merck’s drug, known as boceprevir is also in the race. This medicine boosted cure rates among patients for whom prior therapies had failed and among those who were new to treatment, FDA reviewers said. Boceprevir’s side effects included increased frequency and severity of anemia, according to the report.

Both these drugs are actually protease inhibitors, block an enzyme used by the hepatitis C virus to copy itself. There haven’t been any clinical studies to compare whether one drug is safer or more effective than the other.

Both drugs are likely to win FDA approval and may reach the market in May or June, said Geoffrey Porges, an analyst at Sanford C. Bernstein & Co. in New York. Combined worldwide revenue from both drugs may reach $6 billion to $7 billion within three years.

Hepatitis C affects around 170 million people worldwide and can lead to liver cirrhosis and cancer, according to the Centers for Disease Control and Prevention in Atlanta. No vaccine exists for the virus, which is commonly spread through needle-sharing and can be transmitted sexually in rare cases. The current standard therapy requires almost a year of treatment and cures less than half of patients, said Donald Jensen, director of the Center for Liver Diseases at the University of Chicago Medical Center. Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new anti-virals, which still must be taken in combination with the older drugs ribavirin and interferon.

Clinical trials have shown that Telaprevir cured 84 percent of patients who had previously relapsed after standard therapy, compared with 24 percent who only took peginterferon and ribavirin, FDA staff said in today’s report. Another Vertex study found the drug cured 79 percent of patients who were new to treatment, compared with 46 percent of those on standard therapy alone, the agency said.

Similarly the Merck study found that almost half of patients on boceprevir were able to shorten their treatment time by 12 weeks to 20 weeks. Merck’s research also concluded that boceprevir combined with standard therapy cured 64 percent of chronic hepatitis C patients for whom previous treatments had failed, compared with 21 percent of those who took peginterferon and ribavirin alone. Among hepatitis C patients who were new to treatment, 65 percent of those who took boceprevir, and 38 percent on standard therapy alone, were cured, Merck said.