Racking up yet another year-end approval, the FDA today OK'd Salix Pharmaceuticals' crofelemer for use in treating HIV-related diarrhea. The drug, to be marketed as Fulyzaq, is derived from the red sap of the Croton lechleri plant, making this the second botanical drug ever approved by the FDA.
Analysts don't expect the drug to be a big earner. A Bloomberg report in September noted that the average sales estimate for 2014 was only $33 million. But the agency notes that HIV/AIDS patients often suffer from diarrhea, forcing them to switch their treatments, making this a significant advance for that patient population. And Salix ($SLXP) has counted on Fulyzaq to broaden its product line.
"Currently, there are no FDA-approved therapies for HIV-associated diarrhea," said Dr. Julie Beitz, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition."
This is the second approval for the last day of the year, following a slate in recent days that includes the potential blockbuster Eliquis from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY), Alexza Pharmaceuticals' ($ALXA) win for the antipsychotic drug Adasuve, an OK for Aegerion Pharmaceuticals' ($AEGR) new drug for homozygous familial hypercholesterolemia and NPS Pharmaceuticals' ($NPSP) win on Gattex for treating patients with short bowel syndrome.
- here's the FDA release
Slideshow: FDA Approvals of 2012