For com­pa­nies look­ing to de­vel­op the next mpox (for­mer­ly known as mon­key­pox) an­tivi­rals, the FDA came out with new draft guid­ance yes­ter­day spelling out the de­tails of what such de­vel­op­ment pro­grams should in­clude.

One of the ma­jor points in the draft is the FDA is call­ing for any new mpox treat­ments to run ran­dom­ized con­trolled tri­als with wide racial and eth­nic di­ver­si­ty and those with HIV, as mpox dis­pro­por­tion­ate­ly af­fects these pop­u­la­tions.

“Spon­sors should en­sure that clin­i­cal tri­al sites in­clude ge­o­graph­ic lo­ca­tions with a high­er con­cen­tra­tion of racial and eth­nic mi­nori­ties to re­cruit a di­verse study pop­u­la­tion,” FDA said. “Cur­rent da­ta sug­gest that, in the Unit­ed States, ap­prox­i­mate­ly 40 per­cent of mpox cas­es have oc­curred in in­di­vid­u­als liv­ing with hu­man im­mun­od­e­fi­cien­cy virus (HIV) in­fec­tion. In­di­vid­u­als liv­ing with HIV in­fec­tion should not be ex­clud­ed from clin­i­cal tri­als.”

In Sep­tem­ber 2022, NI­AID start­ed a clin­i­cal tri­al of tecovir­i­mat in the US in col­lab­o­ra­tion with the AIDS Clin­i­cal Tri­als Group (ACTG). The tri­al is en­rolling more than 500 adults and chil­dren with mpox at clin­i­cal re­search sites na­tion­wide.

Tim­o­thy Wilkin, who spe­cial­izes in in­fec­tious dis­ease at Weill Cor­nell Med­i­cine and is work­ing on that tecovir­i­mat tri­al, told End­points News that the guid­ance:

al­so en­cap­su­lates what we de­vel­oped with FDA guid­ance for the cur­rent tecovir­i­mat study.  I think it is im­por­tant that the FDA specif­i­cal­ly called for peo­ple liv­ing with HIV to be in­clud­ed. In de­vel­op­ing STOMP (the phase 3 tri­al of tecovir­i­mat), the FDA en­cour­aged us to max­i­mize in­clu­siv­i­ty. We are en­rolling chil­dren of all ages and preg­nant peo­ple.

Tecovir­i­mat (al­so known as Tpoxx or ST-246) is FDA-ap­proved for the treat­ment of hu­man small­pox dis­ease caused by Var­i­o­la virus in adults and chil­dren, and is man­u­fac­tured by the phar­ma­ceu­ti­cal com­pa­ny SIGA Tech­nolo­gies in New York City.

“The FDA may be re­leas­ing this to pro­vide clar­i­ty for oth­er drugs be­ing con­sid­ered such as brin­cid­o­fovir,” Wilkin added.

The sev­en-page draft al­so in­cludes phar­ma­col­o­gy, tox­i­col­o­gy, vi­rol­o­gy, as well as oth­er clin­i­cal rec­om­men­da­tions.

“The pri­ma­ry end­point for phase 2 or phase 3 clin­i­cal tri­als should be clin­i­cal­ly mean­ing­ful and should demon­strate the clin­i­cal ben­e­fit with a fa­vor­able ef­fect on a mean­ing­ful as­pect of how a par­tic­i­pant with mpox feels, func­tions, or sur­vives,” FDA said.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.