Gilead gets US approval for Sovaldi follow-up Harvoni

Gilead Sciences has won its first approval for a fixed-dose combination product that looks set to reinforce its dominance in the hepatitis C virus (HCV) treatment category.

The US FDA gave the nod on Friday to Harvoni, which combines the active ingredient in Gilead's blockbuster HCV therapy Sovaldi - NS5B polymerase inhibitor sofosbuvir - with NS5A inhibitor ledipasvir in a single, once-daily tablet.

Gilead says the new product can cure as many as 90% of patients within just eight weeks and eliminates the need for interferon and ribavirin therapy, which can be difficult to tolerate.

Sovaldi has eclipsed all prior records to become the most lucrative pharma launch of all time. It added a massive $5.75bn to Gilead's coffers in the first six months of this year thanks to an $84,000-per-course price tag - not including the price of bundled drugs - that has been held up in some quarters as an example of pharma profiteering.

Around 70% of US state Medicaid programmes have implemented controls on Sovaldi prescribing - including prior authorisation requirements based on disease severity  - amid warnings that some healthcare systems may buckle under the strain of providing the drug.

There have been concerns that the launch of Harvoni (and other new HCV therapies from the likes of AbbVie, Bristol-Myers Squibb and Merck & Co) could add to that burden, although Gilead takes issue with that interpretation.

While on paper the new fixed-dose combination is more expensive than Sovaldi at around $94,500 for a 12-week course, the high cure rate after eight weeks means that the average cost per cure is actually close to $63,000, it claims.

Medicaid Health Plans of America (MHPA) - which conducted the analysis on state prescribing restrictions - suggests the reimbursement landscape is evolving quickly in the US as they try to manage the impact of Sovaldi.

"Several states originally listed Sovaldi as a preferred drug, only to list it later this year as a non-preferred drug while also adding additional restrictions," it said.

The efficacy of Harvoni is not in doubt, however, with the FDA's director of the Office of Antimicrobial Products Edward Cox noting that along with Sovaldi and Johnson & Johnson's recently approved Olysio (simeprevir), the new drug promises to "change the treatment paradigm for Americans living with the disease."

Harvoni has also been recommended for approval in Europe, with a final verdict by the European Medicines Agency (EMA) due very shortly.