New Gilead hep C combo Epclusa gains FDA approval


Gilead ($GILD) has seen its new combo of sofosbuvir and velpatasvir gain FDA approval as the company now offers a new cocktail that can treat all 6 types of hep C.

The cocktail treatment, now known as Epclusa, uses the single agent sofosbuvir--the ingredient in its first approved hep C drug Sovaldi--as well as its next-gen follow-up Harvoni, where it was combined with ledipasvir.

Both drugs went on to become multiblockbusters, dominating the new hep C market and boasting massive cure rates compared to its rivals. It can also cater for the hard-to-treat genotype 3 patients. 

This new combination, which is also used with the older injectable drug ribavirin in advanced patients, sees the first-time use of its investigational NS5A inhibitor velpatasvir and has together with sofosbuvir demonstrated stellar results in hep C genotypes 1 through 6, curing 98% of patients within 12 weeks across three Phase III trials.

Although Gilead is dominating the hep C space, there is still pressure from rivals AbbVie ($ABBV), Bristol-Myers Squibb ($BMY) and Merck ($MRK), with the increased demand for quicker, more effective drugs for the liver-destroying disease growing unabated.

But Gilead will hope to outrun its rivals as it’s the first to treat all adults with all genotypes (1-6) with HCV. The drug was also given the thumbs up by European regulators earlier this year. 

“The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype,” said Dr. Ira Jacobson, chairman of the Department of Medicine at Mount Sinai Beth Israel in New York City and a principal investigator in the Epclusa clinical trials.

“Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens.”

The drug has been priced just below $75,000 for a 12-week regimen, around $10,000 less than Sovaldi and $20,000 less than Harvoni.

The company has come under increasing pressure since the 2013 approval of Sovaldi for its price tags, although its latest cocktail treatment certainly isn’t cheap. Bristol’s rival Daklinza, for instance, costs around $63,000 for treatment, although some treatments are combined for certain genotypes, which can increase overall costs.

With a slight nod to the expense of these next-gen treatments, John Milligan, president and CEO of Gilead, said: “Today’s approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens.

“As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible.”

Analysts at Leerink see sales this year reaching $1.8 billion and peaking at $10.3 billion next year--but then will see a quick erosion of sales. It will also likely cannibalize sales from Sovaldi and Harvoni, according to the analysts. 

Gilead was up by 4.3% after midday on the news. 

- check out the FDA’s release
- read Gilead’s statement

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Gilead hep C cocktail cures a pocket of drug-resistant cases
Bristol-Myers gets the approval Gilead didn't want: Daklinza + Sovaldi for hep C