Federal regulators say that some HIV patients who have tested the new Quad pill have reported kidney damage, while other studies suggest that Gilead Sciences Inc. may need additional monitoring.
The four-in-one combination pill from Gilead, the largest maker of AIDS drugs, had a “generally acceptable” safety profile and retained more patients than standard treatments, Food and Drug Administration staff said in a report today.
The agency asked advisers whether patients taking the HIV drug should undergo extra testing to monitor for kidney complications.
The medicine is designed to have fewer side effects than current treatments. Approval of the Quad pill is crucial for Foster City, California-based Gilead, said Robyn Karnauskas, an analyst with Deutsche Bank AG in New York. The drugmaker is facing the loss of half of its revenue from patent expirations on AIDS therapies starting in 2018.
If approved the new medicine may generate as much as $4 billion in annual sales, she said.
“It is really important for Gilead as a stock that the Quad comes to market and there is nothing bad in the data,” Karnauskas said in a telephone interview. “It will really hurt the stock if this drug doesn’t come to market.”
An FDA review of studies funded by Gilead found a higher number of kidney problems reported in people taking Quad compared with other HIV treatments. Those side effects included four cases of kidney failure and one case of a rare syndrome where substances aren’t absorbed into the blood stream by the kidneys.
Still, there were fewer patients who stopped taking Quad early because of side effects and the incidence of side effects was similar to other drugs, the FDA said.
Karnauskas said she isn’t concerned that the kidney risk may prevent the drug from getting to market.
“It is just a minor detail, which is why I’m not worried,” she said.
Company-sponsored studies have shown Quad works as well as Atripla. Eighty-eight percent of patients in a 48-week study who took Quad had no detectable levels of HIV in their blood compared with 84 percent of those taking Atripla, according to research presented in March at the Conference on Retroviruses and Opportunistic Infections in Seattle.
The FDA is scheduled to decide by Aug. 27 whether to approve Quad for U.S. sale.