Gilead notches FDA approval for first all-genotype hep C med, Epclusa

epclusa

With an FDA approval Tuesday, Gilead Sciences’ Epclusa became the first medicine indicated to treat all major hep C genotypes. But the Foster City, CA-based Big Biotech is taking an uncharacteristic pricing strategy with its franchise-advancing med: it’s listing it at a discount to predecessors.

A combination of Sovaldi (sofosbuvir) and new medicine velpatasvir, Epclusa will cost $74,760 for a 12-week regimen, Bloomberg reports, less than Sovaldi or Gilead’s superstar Harvoni, which ring in at $84,000 and $94,500 before discounts.

Epclusa’s approval “represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens,” CEO John Milligan said in a statement. He added that it could possibly “eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings.”

Milligan, speaking with Bloomberg, said Gilead’s Harvoni will continue to reign in genotype 1 due to its shorter treatment time. He added that Epclusa will begin to replace Sovaldi in genotypes 2 and 3.

Gilead’s pricing decision comes as the biotech continues to face criticism over the costs of its meds, though its strategy has turned Sovaldi and Harvoni into huge sellers and raised the company’s fortunes in recent years. It’s also possible that Epclusa’s sticker price is in part a response to a yearlong public and political firestorm over pharmaceutical costs.

In one example of the outrage, earlier this month, Los Angeles-based AIDS Healthcare Foundation launched a campaign entitled “Gilead Greed Kills!” and conducted protests outside of the company’s headquarters and during a Goldman Sachs Healthcare Conference presentation.

Despite the protests, Gilead has dominated in the hep C field, raking in more than $19 billion from Sovaldi and Harvoni last year. But it also faces competition from AbbVie, Bristol-Myers Squibb and Merck, which recently priced its Zepatier at $54,600 before discounts.

Those market forces may have had some play in Gilead's recent hep C sales troubles. Gilead missed its EPS expectations for the first quarter, largely due to slower-than-expected Sovaldi and Harvoni sales.

The FDA approved Epclusa for hep C treatment in patients with and without cirrhosis; the former group will take the med in combination with ribavirin.

- here’s the FDA statement
- and Gilead’s release
- and the Bloomberg story
- here's FierceBiotech's take

Related Articles:
Milligan's shake-up at Gilead seen as reassuring to investors
Planes, hearses and caravans dot 'Gilead Greed Kills!' protests from AIDS foundation
Merck's 'aggressive' hep C pricing helps it steal share in Q1
Gilead's hep C slowdown cues Q1 miss on sales, profit

Read more on