New Gilead and AbbVie hepatitis C combos filed in EU
Europe’s regulator has granted eight-week hepatitis C treatments from Gilead and AbbVie a fast review, as the companies compete to offer faster, patient-friendly cures with fewer side effects.
Both will get an accelerated assessment, reserved for medicines that could greatly improve public health, or are highly innovative.
The European Medicines Agency’s assessment allows for a 150-day review period, as opposed to the standard 210-day review, not counting clock stops while the regulator gets feedback from questions.
The EMA began its review of Gilead’s combination of sofosbuvir, velpatasvir and voxilaprevir last week, and its review of AbbVie’s glecaprevir/pibrentasvir began yesterday.
Gilead has made great play of its combination’s use as a salvage therapy lasting 12 weeks, for patients who have failed to respond to other direct-acting antiviral therapies, although it can also be taken as an eight-week course in treatment-naïve patients.
It will be taken as a single tablet, once daily. It combines the active ingredients in Gilead’s Epclusa (sofosbuvir+velpatasvir), plus a new drug, voxilaprevir. Epclusa is approved in the US and EU in all six major hepatitis C genotypes, but treatment is based on a course lasting 12 weeks.
Meanwhile, AbbVie said its treatment may provide an eight-week, daily, ribavirin-free treatment option for all major genotypes (1-6), in patients without cirrhosis.
The drug, taken in a single daily dose of three tablets, offers an additional option for patients with compensated cirrhosis (Child-Pugh A).
Discovered through a collaboration with Enanta, AbbVie is also studying the combination in patients with treatment challenges such as genotype 3, patients not cured with previous treatments and those with chronic kidney disease, including patients on dialysis.
It is one of a group of drugs the firm hopes will prop up sales as patents expire on its big-selling inflammatory diseases drug, Humira.
Like Gilead’s latest combo it is also under review in the US following a filing in December.
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