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FDA adds liver warning to AbbVie hepatitis C drugs

WASHINGTON (AP) — Federal health officials are warning doctors and patients that dual hepatitis C drugs from AbbVie can means life-threatening liver repairs in patients with modernized forms of a disease.

The Food and Drug Administration pronounced Thursday it will need AbbVie to supplement new warnings to Viekira Pak and Technivie after reported deaths and liver transplants in patients who already had liver repairs caused by hepatitis C.

The warning could reshape a flourishing margin of cost drugs to provide a virus, that also includes Gilead Sciences’ blockbuster drugs Sovaldi and Harvoni.

Jefferies researcher Brian Abrahams wrote in an investment note that a warning is a “moderate positive” for Gilead Sciences. But he combined that AbbVie’s Viekira Pak was already approaching to be “displaced” by a identical drug from Merck Co. Inc. subsequent year.

Bernstein researcher Tim Anderson remarkable that’s AbbVie’s drug requires patients to take 4 to 6 pills per day. That compares negatively with a once-per-day fast for Gilead’s Harvoni and Merck’s arriving pill, that is slated for capitulation in early 2016.

“In a ultra-competitive hep C market, this is expected a deleterious event,” Anderson wrote in an investment note.

Shares of North Chicago, Illinois-based AbbVie Inc. plummeted $5.56, or 10 percent, to tighten during $48.27 in trade Thursday.

Nearly 3 million Americans have a virus, that develops solemnly over decades and, if left untreated, can means liver disaster and liver cancer, requiring transplant.

The FDA pronounced in an online posting that AbbVie’s drugs have been associated to mixed cases of serious liver repairs — some of them deadly — in patients who already had liver cirrhosis, irrevocable scarring of a organ. The organisation dynamic 26 such events were expected associated to a drugs, with a liver repairs customarily occurring within 4 weeks of starting treatment.

AbbVie pronounced in a matter it is adding a warning to a drugs that they contingency not be used in patients with assuage to serious liver impairment.

“Patient reserve is of a pinnacle regard to AbbVie,” a association pronounced in an emailed statement.

AbbVie’s drugs are partial of a new call of pill-only combinations that heal some-more patients and means fewer side effects than comparison hepatitis C treatments, that compulsory injections and caused flu-like side effects.

Viekira Pak treats a many common form of hepatitis C, famous as genotype 1, that accounts for about 75 percent of all U.S. cases. Technivie, authorized in July, treats one of a slightest common forms of hepatitis C.

Gilead Sciences primarily dominated a space, raking in over $9.4 billion in sales for Sovaldi in a initial full-year on a market. The association followed that capitulation with a launch of a multiple pill, Harvoni, to provide a most broader organisation of hepatitis C patients.

While doctors and patients have embraced a new drugs, insurers have pushed behind over their sky-high prices — generally $83,000 or some-more for one march of treatment.

The launch of AbbVie’s pill, Viekira Pak, was welcomed as a much-needed aspirant in a field. Since then, providers have been forcing Gilead and AbbVie to contest on cost to get elite station in their formularies of authorized drugs, and have been winning estimable discounts.

Express Scripts, a nation’s largest provider of pharmacy benefits, has thrown a weight behind AbbVie’s drugs, refusing to cover competing products from Gilead and Johnson Johnson.

Shares of Foster City, California-based Gilead Sciences Inc. rose $5.87, or 5.8 percent, to tighten during $107.60.

Article source: http://www.stltoday.com/news/science/fda-adds-liver-warning-to-abbvie-hepatitis-c-drugs/article_103d09f8-1565-575b-8b90-ae317adad6c6.html

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