Gilead’s filgotinib is getting a chance at a new indication in Europe after the US regulators handed down a CRL a few months ago.
The company announced Monday afternoon that the EMA is taking up a second review for the JAK1 inhibitor, this time in ulcerative colitis. Marketed as Jyseleca on the continent, filgotinib has already been approved for adults with moderate to severe rheumatoid arthritis who are resistant to other anti-rheumatic drugs.
Gilead and its marketing partner Galapagos NV say that the new application is backed by a Phase IIb/III study that showed a significantly higher share of patients saw remission after 9 weeks, and maintained their remission at week 58, compared to placebo.
The new UC application is only for the higher dose of filgotinib — its once-daily, 200 mg pill. For rheumatoid arthritis, filgotinib is approved in Europe at 100 mg and 200 mg levels.
Monday’s submission comes just a few months after the FDA surprisingly turned down filgotinib’s application in the US. That put the drug further behind its main competition, AbbVie’s Rinvoq, which was approved in August 2019.
Ultimately, US regulators wanted to see more data from two ongoing safety studies of filgotinib.
GW Pharmaceuticals launches PhIII trial for MS candidate made with cannabis extracts
After its Phase III program in the US got delayed amid the pandemic, GW Pharmaceuticals has finally screened its first patient for a study evaluating the botanical candidate nabiximols for MS-associated spasticity.
The drug, an oral spray, consists of extracts of the cannabis plant, including the cannabinoids THC and CBD. It’s already approved in 25 countries based on pivotal trials conducted in Europe, and marketed as Sativex.
There’s been growing interest in the clinical use of cannabis. GW currently has the only FDA-approved cannabis-derived drug: Epidiolex (cannabidiol), which was handed an OK in 2018 after GW demonstrated its ability to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome.
There are three other cannabis-related drug products approved by the FDA: Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone).
Working with the US subsidiary Greenwich Biosciences, GW will evaluate the safety and efficacy of nabiximols for spasm frequency in 446 patients over a 12-week period. The biotech plans on launching additional Phase III muscle tone studies and spasm frequency studies later this year and throughout next year.
“Given the rigorous studies already conducted on the medicine outside of the U.S., and positive discussions with the FDA, we believe that we have a clear path to an NDA submission, potentially as soon as next year, and a significant second product opportunity for GW in the U.S.,” GW CEO Justin Gover said in a statement.