- The Food and Drug Administration approved Gilead's Vemlidy (tenofovir alafenamide or TAF) for the treatment of hepatitis B in patients with compensated liver disease, the company reported Thursday. The company also got a positive opinion from the Committee for Medical Products for Human Use (CHMP) in Europe.
- In a Nov. 11 statement, Gilead pointed to clinical data that showed its new drug could treat the hep B virus at less than one-tenth the dose of its predecessor, tenofovir disoproxil fumarate (TDF). Because of that, Vemlidy is much less damaging to patients' bone density and kidney health, the company claims.
- The Foster City, CA-based biopharma plans to unveil more data about the drug's active ingredient at the American Association for the Study of Liver Disease's annual Liver Meeting, which goes from Nov. 11 through Nov. 15.
Vemlidy's approval may help turn around recent declines Gilead has seen across its hepatitis products. Its hep C drugs Epclusa, Harvoni and Sovaldi, for instance, had $3.3 billion in sales during the third quarter, $1.5 billion less than the same period in 2015, according to the company's most recent 10-Q filing with the Securities and Exchange Commission.
But new HIV and antiviral products that incorporated tenofovir alafenamide (TAF) helped offset those losses, Gilead said. Those treatment areas brought in $3.5 billion during the third quarter, up from $2.9 billion the year prior.
The FDA first green lit TAF in November 2015 with the approval of Gilead's HIV drug Genvoya. That product has brought in more than $920 million throughout 2016. And with patent protection for TDF set to expire in 2017 and 2018, the company is banking on the newer version of the drug to offset potential competition. Currently, TDF is used in products such as Atripla, Eviplera, Stribild and Truvada.
The road to approval for more TAF-based medicines may be bumpy, though. The AIDS Healthcare Foundation filed a lawsuit against Gilead early this year, taking aim at the company for keeping the safer, more effective version of its drug, TAF, off the market in an effort to extend the lifecycle of its older TDF-based products.
"In a relentless effort to maximize its profits, Gilead manipulated the patent system and engaged in anticompetitive practices to prevent economical access to TAF," the foundation said in the lawsuit filed with the U.S. District Court for the Northern District of California.
"Because of the weakness of Gilead's patents covering TAF, Gilead has engaged in anticompetitive business practices aimed at keeping competing TAF drugs off the market for years," the foundation added. "Gilead has and continues to make TDF available as a standalone product … whose only significant difference [from TAF] is that is it absorbed more efficiently and thus avoids bone and kidney toxicity."
While the court ultimately ruled in favor of Gilead in that case, the foundation announced in July it would pursue an appeal.