• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar

Family Health Corner

News That Affects Your Family's Health

FAMILY HEALTH CORNER
News That Affects Your Family's Health

  • Home
  • About/Contact
  • CHILDREN
  • HEALTH NEWS/TRENDS
  • INSURANCE
  • MEN
  • MENTAL HEALTH
  • WOMEN

Merck’s women’s health spinout snags mid-stage candidate for preterm birth; Keytruda nails down TNBC approval after March CRL – Endpoints News

July 27, 2021 by Staff Reporter

Near­ly two months af­ter spin­ning out from Mer­ck, women’s health busi­ness Organon has struck its first half-bil­lion-dol­lar deal.

Organon $OGN has promised $25 mil­lion up­front and an­oth­er $475 mil­lion in biobucks for world­wide rights to ebopiprant, Ob­sE­va’s in­ves­ti­ga­tion­al treat­ment for preterm la­bor. Ebopiprant, a se­lec­tive prostaglandin F2α (PGF2α) re­cep­tor an­tag­o­nist, was orig­i­nal­ly li­censed from Mer­ck KGaA in 2015. The can­di­date works by re­duc­ing in­flam­ma­tion and uter­ine con­trac­tions.

“This de­vel­op­ment-stage as­set is be­ing stud­ied in one of the most cru­cial un­met needs for women glob­al­ly,” Organon CEO Kevin Ali said in a state­ment. There are cur­rent­ly no ap­proved drugs for the acute treat­ment of preterm la­bor in the US.

Back in No­vem­ber, Ob­sE­va said ebopiprant re­duced the de­liv­ery of preg­nan­cies (not in­clud­ing twin preg­nan­cies) by 55% at 48 hours when ad­min­is­tered with atosi­ban (the ex-US stan­dard of care), com­pared to atosi­ban alone. Over­all, 12.5% of women in the treat­ment arm de­liv­ered ba­bies with­in 48 hours of start­ing treat­ment, com­pared to 21.8% in the place­bo arm, Ob­sE­va said of the Phase IIa tri­al.

“The in­ci­dence of ma­ter­nal, fe­tal and neona­tal ad­verse events were com­pa­ra­ble be­tween sub­jects in the ebopiprant group and the place­bo group,” the com­pa­ny said.

Organon of­fi­cial­ly spun out from Mer­ck on June 3 with a port­fo­lio of more than 60 med­i­cines, in­clud­ing Nex­planon, its long-ac­tive re­versible con­tra­cep­tive. Nex­planon is one of the top hor­mon­al con­tra­cep­tives in the coun­try, ac­cord­ing to IQVIA da­ta, and grew at an an­nu­al com­pound growth rate of 9% be­tween 2014 and 2019. — Nicole De­Feud­is 

Keytru­da nails down TNBC ap­proval af­ter March CRL

Mer­ck’s block­buster check­point in­hibitor Keytru­da has won an­oth­er FDA ap­proval, this time in a line of triple-neg­a­tive breast can­cer.

Reg­u­la­tors hand­ed down the green­light for the treat­ment of pa­tients with high-risk ear­ly-stage TNBC in com­bi­na­tion with chemo, as neoad­ju­vant and then con­tin­ued as a sin­gle agent as ad­ju­vant treat­ment af­ter surgery. The thumbs up marks the 30th in­di­ca­tion for which the Keytru­da is ap­proved in the US, Mer­ck said.

Ad­di­tion­al­ly, the FDA con­vert­ed the Keytru­da-chemo com­bo ac­cel­er­at­ed ap­proval in lo­cal­ly re­cur­rent un­re­sectable or metasta­t­ic TNBC for tu­mors ex­press­ing PD-L1 to full ap­proval.

The TNBC ap­proval comes af­ter the FDA hand­ed Mer­ck a rare CRL for Keytru­da back in March, af­ter an ad­comm unan­i­mous­ly vot­ed to rec­om­mend wait­ing for more da­ta for the study in ques­tion. Ad­vis­ers and reg­u­la­tors point­ed to­ward con­cerns over the tri­al’s event-free sur­vival pri­ma­ry end­point over place­bo, say­ing re­searchers hadn’t watched pa­tients long enough af­ter treat­ment to de­ter­mine EFS and OS.

But a few weeks lat­er, Mer­ck claimed a win in the study af­ter claim­ing it reached the in­ter­im analy­sis check­point. The tri­al, known as KEYNOTE-522, met its dual pri­ma­ry end­points of event-free sur­vival and patho­log­i­cal com­plete re­sponse. — Max Gel­man

###[ad_2]
Originally Appeared Here

Filed Under: WOMEN

Primary Sidebar

More to See

Medical startup has Stonington native in mind

Oct. 6—When over 100 people gather on Tuesday, Oct. 12, at Stonington Country Club for the first Andrew Heylmun Invitational golf tournament, they'll … [Read More...] about Medical startup has Stonington native in mind

Walking your way: NAMI hosting virtual walk for mental health this weekend | News, Sports, Jobs

MARQUETTE — There’s never a bad time to think about your mental health: Where it stands, how you can improve it, and where to go for help if you need … [Read More...] about Walking your way: NAMI hosting virtual walk for mental health this weekend | News, Sports, Jobs

18 ft Purple Crush Water Slide Rental

https://abouttobounce.com - BOOK YOUR Inflatable Party Rental from About To Bounce Inflatables, TODAY! Inflatable Bounce House and Inflatable Water … [Read More...] about 18 ft Purple Crush Water Slide Rental

Privacy Policy | Terms and Conditions | About/ Contact
As an Amazon Associate I earn from qualifying purchases.
Copyright © 2022 · FAMILY HEALTH CORNER . Log in