Painted as the follow-up drug to megablockbuster Humira, AbbVie’s JAK med Rinvoq is already notching blockbuster forecasts from market watchers. A green light to treat European patients should give the rheumatoid arthritis med a leg up in reaching that lofty goal.
Thursday, the EU’s Committee for Medicinal Products for Human Use (CHMP) gave the go-ahead to Rinvoq to treat RA patients who have failed on a prior disease-modifying therapy
The positive CHMP opinion, among seven issued by the key committee this go-round, puts the drug a step closer to new markets after its FDA nod and U.S. rollout in mid-August.
AbbVie said in a release that it expects a full European Commission approval for Rinvoq within 67 days.
Rinvoq’s win wasn’t the only news from a busy day for the CHMP: Six other meds were also given a positive opinion to treat European patients, including a controversial ketamine derivative from Johnson & Johnson and an Ebola vaccine from Merck.
Spravato, J&J’s nasal ketamine-derivative spray, received a nod to treat patients with major depressive disorder (MDD) after its FDA approval back in March. The med was approved as the first new treatment for MDD in decades but only in patients who've failed two or more previous treatments.
In September, Spravato added to standard-of-care notched a trial win in reducing primary symptoms after 24 hours, compared with a combination of placebo and standard-of-care therapy. While a small subset of patients fall under that potential indication, J&J touted the new data as part of a “robust package” of results in MDD.
Merck’s Ebola vaccine Ervebo, already at work fighting a long-running outbreak in Central Africa, also won backing from the key EU committee.
Back in January, Merck pledged 120,000 doses to aid officials combating the virus, on top of the 100,000 doses it had previously shipped to the World Health Organization (WHO). Congo’s health ministry designated the outbreak last August.
In May, after Merck’s supplies ran short, the WHO opened the door to an experimental vaccine from J&J to fill in the gaps in treating patients.
The four other drugs winning go-aheads from CHMP Thursday were Xeris’ shelf-stable glucagon injector Baqsimi, Melinta’s Quofenix for the treatment of adult patients with acute bacterial skin and skin structure infections, a pegfilgrastim biosimilar from Mundipharma and Amgen’s bone drug Evenity, which previously had not been recommended by the committee.