
Rinvoq nabs new approval in second-line UC; Sensorion says its failed drug now works in subset analysis
AbbVie’s Rinvoq racked up another approval late Wednesday afternoon.
The drug is now OK’d in adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers, AbbVie said in a press release. It’s the first approval for the drug in gastroenterology, the company added, with data stemming from three Phase III studies.
“There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome,” said Thomas Hudson, AbbVie CSO. “With the approval of Rinvoq as a new treatment option, AbbVie continues our leadership in advancing research that can help impact the lives of people living with ulcerative colitis.”
Wednesday’s approval comes a few months after the agency slapped a new warning on the drug after Pfizer’s Xeljanz saw increased side effects, relegating the drug to second-line use in rheumatoid arthritis. The warning came amid the backdrop of a larger safety saga playing out for the entire JAK class of drugs. — Max Gelman
Sensorion claims victory on exploratory endpoints after PhII failure
French biotech Sensorion got hammered back in January after its only clinical stage drug failed to meet the primary endpoint in a Phase II study — losing 40% of its share value after the news was announced about its lead drug SENS-401, a treatment of sudden sensorineural hearing loss (SSNHL).
Today, the biotech says it has some more data. And this time, it says that they found some statistically significant treatment effects in specific populations after they reviewed exploratory endpoints. Those include patients suffering from profound hearing loss treated with corticosteroids seeing an improvement of 19-26 dB from baseline compared to placebo.
Exploratory endpoints, however, are generally considered far less conclusive than endpoints that were set ahead of time, and are generally used only to design future trials, rather than to offer definitive answers on efficacy.
Investors responded favorably to the new development, initially skyrocketing the stock up over 43% before stabilizing at around a 20% increase.
The drug is still in play in a collaboration on hearing preservation following cochlear implants. Sensorion and partner Cochlear Limited are moving forward with a trial and have submitted trial design plans to regulators in Australia and France. — Paul Schloesser