FDA Approves AbbVie's All-Oral Hepatitis C Drug Viekira Pak

December 22, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

The U.S. Food and Drug Administration has followed market expectations and approved AbbVie 's hepatitis C treatment Viekira Pak this week, but the limited uses listed on its label have market analysts disappointed in its so far constricted range of use.

The package includes an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including cirrhotics.

The news was expected and has now released the first FDA-approved drug therapy that contains a NS5A inhibitor, a NS3/4A protease inhibitor and a non-nucleoside NS5B polymerase inhibitor, drugs that attack three separate stages of the disease to control it in patients.

The company’s executives said they were pleased with the regulator’s Friday decision and had high hopes for wider applications of the drug.

"We are proud of the work of our research and development organization to bring this important therapy, offering high cure rates, to patients with hepatitis C. We believe appropriate patients, regardless of their fibrosis stage, should have broad market access to Viekira Pak, and we are committed to supporting access to this therapy," said Richard Gonzalez, chairman of the board and chief executive officer of AbbVie, in a statement. "This is the first of several potential new therapies that we are advancing to treat a multitude of serious disease states, and we anticipate bringing them to market in the coming years."

For their part, Wall Street analysts remained sanguine about the drug’s approval, but expressed disappointment at the so far limited approved uses for it among a growing population of hepatitis C patients—particularly those in prison or covered under large benefits providers like Express Scripts or Medicaid and Medicare.

“AbbVie's Viekira Pak was approved Friday afternoon as expected, with a label that failed to achieve the full advantage some had expected for the company's powerful but cumbersome 3d regimen. Viekira Pak requires ribavirin for all G1a and cirrhotics,” wrote analyst Geoffrey Porges for Sanford Bernstein in a note to investors Monday.

“Like Gilead 's Harvoni, AbbVie's duration of treatment was extended to 24 weeks for genotype 1a with cirrhosis (approximately 10 percent of patients) and only in genotype 1b without cirrhosis (20 percent of g1 patients) did Abbvie escape Ribavirin,” he said.