The FDA said the more serious problems were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.
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The shares of AbbVie fell 10% to $48.27 on Thursday after the FDA posted the safety alert.
“Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury”, the FDA said.
Federal health officials are warning doctors and patients that two hepatitis C drugs from AbbVie can cause life-threatening liver injury in patients with advanced forms of the disease.
VIEKIRA PAK with and without ribavirin (RBV) remains indicated for genotype 1 (GT1) HCV patients with compensated cirrhosis, including Child-Pugh A. The safety and efficacy of VIEKIRA PAK, with and without RBV, has been studied in Phase 3 trials in more than 2,300 patients and is one of the recommended regimens in the AASLD guidelines for these patients.
Since the approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 worldwide cases submitted to FAERS were considered to be possibly or probably related to Viekira Pak or Technivie.
AbbVie said a causal relationship between the treatments and the adverse events hasn’t been established, but the drugs couldn’t be ruled out as a cause.
The drugs, along with other new hepatitis C treatments, have also spurred debate over rising prescription costs. The drug fetched $616 million in sales between January and June 2015.
“We believe that the inclusion of potential serious liver injury in the label will meaningfully commercially impair Viekira Pak sales”, said Evercore ISI analyst, Mark Schoenebaum, said in an email to clients.
Shares of Gilead closed Thursday up 5.8% at $107.60, with a consensus analyst price target of $124.25 and a 52-week trading range of $85.95 to $123.37. But he added that AbbVie’s Viekira Pak was already expected to be “displaced” by a similar drug from Merck & Co.
Gilead was first to market with a hepatitis C cure, and its Harvoni treatment is a once-a-day pill, in contrast to AbbVie’s treatment, which requires multiple pills.
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“Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy”, he said.
