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

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).