July 5, 2022

Second Entry Wins Approval as Hepatitis C Drug

Incivek, as the drug will be called, is expected to be the first big product for Vertex, and the first it will sell on its own, and is expected to allow the company to reach profitability.

Vertex, based in Cambridge, Mass., has been in existence more than 20 years and by its own account has spent more than $4 billion. It developed two H.I.V. drugs sold by GlaxoSmithKline, but the royalties were not enough to make it profitable.

“With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” Dr. Edward Cox, an official with the Food and Drug Administration, said in a news release issued by the agency Monday morning announcing the approval.

Merck’s drug, Victrelis, also known as boceprevir, was approved on May 13.

Both drugs inhibit the protease enzyme, which the hepatitis C virus needs to replicate itself inside the human body. In that sense, both drugs borrow from the approach used successfully by drugs that combat H.I.V. by inhibiting viral enzymes.

Many analysts expect Vertex’s drug, which is also known as telaprevir, to outsell Merck’s because it looked in clinical trials to be somewhat more effective, though the two drugs were never compared head to head.

Also, the treatment schedule using Vertex’s drug is less complex. Incivek is taken three times a day with a total of six pills daily, half as many as for Merck’s drug.

In a clinical trial, 79 percent of those treated with Incivek and the existing treatment had what is considered an effective cure, compared to 46 percent for those getting the existing treatment alone.

Vertex said Incivek would cost $49,200 for the full course of treatment. Merck’s drug would cost $26,400 to $48,400 depending on the treatment’s duration. They are used in addition to existing therapies, which cost about $15,000 to $30,000.

An estimated 3.2 million Americans are infected with hepatitis C, which can cause severe liver damage and liver cancer, though usually only after many years and in only some of those infected.

The existing treatment consists of weekly injections of alpha interferon combined with ribavirin pills taken every day. The treatment can last nearly a year and has side effects including flu-like symptoms, anemia and depression.

Incivek is taken for the first 12 weeks of therapy along with the other two drugs. After that, the two other drugs are continued without Incivek. More than half of patients getting Incivek can complete their treatment in 24 weeks instead of the usual 48, according to the F.D.A.

Incivek can cause a severe rash and anemia. Other side effects include nausea, vomiting, fatigue and diarrhea.

Article source: http://feeds.nytimes.com/click.phdo?i=2b05e63f205702333730a5e492673351

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