The FDA is work­ing on a new flu vac­cine frame­work, which a se­nior FDA of­fi­cial told End­points News would ad­dress "a lot of prob­lems" re­lat­ed to strain se­lec­tion, year-over-year changes in ef­fi­ca­cy, and the spe­cif­ic as­says to eval­u­ate ef­fec­tive­ness that are "a lit­tle an­ti­quat­ed."

The of­fi­cial al­so raised the pos­si­bil­i­ty of ad­di­tion­al reg­u­la­to­ry ac­tion on a chikun­gun­ya vac­cine sold by Val­ne­va, cit­ing safe­ty con­cerns.

The move to­ward a new flu frame­work comes as FDA Com­mis­sion­er Mar­ty Makary last month pre­dict­ed a uni­ver­sal flu vac­cine will be avail­able with­in the next five years, “in­clud­ing po­ten­tial bird flu vari­ants.” Clin­i­cal tri­als for uni­ver­sal in­fluen­za vac­cines are ex­pect­ed to be­gin next year, with FDA ap­proval tar­get­ed for 2029, ac­cord­ing to HHS.

Bay­er said the FDA has ex­tend­ed its re­view of the com­pa­ny’s hot flash treat­ment by up to three months.

The FDA con­clud­ed that it needs ad­di­tion­al time to re­view the non­hor­mon­al drug elin­zane­tant, the Ger­man phar­ma said in an up­date on Fri­day. Bay­er said no con­cerns were raised about the drug's ap­prov­abil­i­ty dur­ing its cor­re­spon­dence with the agency. The com­pa­ny pre­vi­ous­ly said it planned to launch the prod­uct in the US in the sec­ond half of the year.

“We are con­fi­dent in the po­ten­tial of elin­zane­tant to pro­vide mean­ing­ful clin­i­cal ben­e­fit to women pend­ing reg­u­la­to­ry ap­proval,” Yesmean Wah­dan, se­nior vice pres­i­dent and head of med­ical af­fairs for Bay­er's North Amer­i­can phar­ma unit, said in a re­lease.

A spokesper­son for HHS de­clined to com­ment on an ap­pli­ca­tion un­der re­view.

The Eu­ro­pean Med­i­cines Agency’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) land­ed on a num­ber of high-pro­file de­ci­sions this week, in­clud­ing chang­ing course on Eli Lil­ly’s Alzheimer's drug in cer­tain pa­tients and rec­om­mend­ing Gilead’s twice-year­ly HIV pre­ven­tive ap­proach.

Over­all, CHMP said Fri­day that it is en­dors­ing the au­tho­riza­tion of 13 new med­i­cines. It al­so said that the Eu­ro­pean Com­mis­sion should re­ject three drugs, in­clud­ing Sarep­ta’s trou­bled Duchenne drug Ele­v­idys, which Roche is li­censed to dis­trib­ute in Eu­rope.

Lil­ly’s Alzheimer's drug Kisun­la ini­tial­ly re­ceived a neg­a­tive opin­ion in March. At the time, CHMP not­ed the ben­e­fits of the drug did not out­weigh the risks of pa­tients de­vel­op­ing bleed­ings and swellings of the brain called amy­loid-re­lat­ed imag­ing ab­nor­mal­i­ties (ARIA), which can be fa­tal. Kisun­la was ap­proved in the US in Ju­ly 2024.

Eu­ro­pean Med­i­cines Agency’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) said Fri­day that Sarep­ta’s Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py Ele­v­idys should not be ap­proved in Eu­rope.

The com­mit­tee said it rec­om­mend­ed against ap­proval be­cause Ele­v­idys' piv­otal tri­al failed to demon­strate an ef­fect on pa­tients' move­ment abil­i­ties.

The ver­dict cuts off a po­ten­tial rev­enue stream for Ele­v­idys’ li­censee, Roche, which holds rights out­side the US un­der a 2019 deal.

Roche is al­lowed to ask for re-ex­am­i­na­tion of the opin­ion in the next 15 days. It said in a re­lease that it would work with the EMA on a po­ten­tial path for­ward for Ele­v­idys in Eu­rope.

Sarep­ta's share price SRPT fell by as much as 16% pre-mar­ket. Sarep­ta would like­ly have re­ceived a mile­stone pay­ment on Eu­ro­pean ap­proval of Ele­v­idys, as well as roy­al­ties on Eu­ro­pean sales.

→ Alexan­dra Sny­der has bid adieu to Flag­ship's Gen­er­ate:Med­i­cines, which slashed its head­count by 10% last week, af­ter three years as CMO and EVP, R&D, and is re­turn­ing to her old stomp­ing grounds at Mer­ck as SVP, head of trans­la­tion­al med­i­cine & drug on­col­o­gy. Sny­der was orig­i­nal­ly at Mer­ck from 2018 to 2021, cul­mi­nat­ing in her role as as­so­ciate VP, glob­al clin­i­cal de­vel­op­ment. Sny­der's ré­sumé al­so boasts of six years at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, and time spent at Al­lo­gene Ther­a­peu­tics, 76bio and Two Riv­er, among oth­ers. Ear­li­er this month, Mer­ck said at the In­ter­na­tion­al AIDS So­ci­ety con­fer­ence on HIV Sci­ence that it was mov­ing for­ward with Phase 3 plans for MK-8527, its once-month­ly oral pre­ven­tion tool for HIV.