With a revolutionary approach to hepatitis C and a price tag of $84,000 per 12-week treatment course, analysts expected big sales from Gilead's Sovaldi. Some even forecast it would reach $9 billion or more by 2017, at which level it would surpass Pfizer's Lipitor to take the crown for biggest-selling drug of all time. But none expected the exponential growth the drug is posting right now.
How can Medicaid pay for the pricey new generation of hepatitis C drugs? Insurers want to know. And they're now asking state health agencies to pitch in, Reuters reports.
AbbVie's promising oral hepatitis C combo treatment is rolling along toward FDA approval, and the drugmaker unveiled a deeper set of Phase III data in which the cocktail cured nearly 100% of patients in a tough-to-treat population.
Bristol-Myers Squibb has picked up its second "breakthrough" drug designation for a daclatasvir-based, all-oral combo for hepatitis C from the FDA, potentially shaving some regulatory time off its late-stage program as developers scramble to hijack market share from Gilead's pioneering approach.
Right on schedule, Gilead Sciences has submitted its combination hepatitis C treatment for FDA approval, inching toward the era of interferon-free treatment and widening its lead on rival AbbVie.
AbbVie has wrapped up its late-stage studies of a promising interferon-free hepatitis C cocktail, setting the stage for near-term FDA application and a showdown with rival Gilead Sciences.
The European Commission approved the pill being used in tandem with a once-daily oral nucleotide analogue polymerase inhibitor for adults suffering from chronic hepatitis C infection.
Gilead Sciences just rolled out its much-anticipated hepatitis C treatment Sovaldi (sofosbuvir) last month. Now, the company's commercial chief is saying sayonara. EVP Kevin Young will retire Feb. 4, leaving his team to soldier on alone with the Sovaldi launch.
Gilead unveiled a package of stellar late-stage cure rates for its closely-watched hepatitis C combination of the newly approved "nuke" Sovaldi (sofosbuvir) and the NS5A inhibitor ledipasvir, putting it on a short path to the FDA with a new drug application planned for the first quarter of the coming year.
Gilead Sciences can take the sort of pricing protest that greeted its breakthrough hepatitis C treatment Sovaldi this week--the kind from access-to-medicine advocates. But when payers balk, that's a different story. A horror story, even, that could frighten drugmakers long accustomed to pricing freedom in the U.S.