EMA makes new rec­om­men­da­tions for Im­bru­vi­ca, med­i­cines with ter­li­pressin over res­pi­ra­to­ry and car­dio­vas­cu­lar risks

The EMA is hand­ing out a new rec­om­men­da­tion sur­round­ing J&J and Ab­b­Vie’s can­cer drug Im­bru­vi­ca and some med­i­cines con­tain­ing ter­li­pressin.

On Fri­day, the EMA’s safe­ty com­mit­tee (PRAC) stat­ed that it has tak­en new mea­sures to re­duce the risk of res­pi­ra­to­ry fail­ure and sep­sis when med­i­cines con­tain­ing ter­li­pressin that are used to treat peo­ple with he­pa­tore­nal syn­drome (HRS-1), par­tic­u­lar­ly for pa­tients with ad­vanced acute-on-chron­ic liv­er dis­ease or ad­vanced kid­ney fail­ure.

Health­care of­fi­cials should con­sid­er giv­ing med­i­cines con­tain­ing ter­li­pressin on a drip as it may re­duce any side ef­fects as well as mon­i­tor­ing any pa­tients for signs of repara­to­ry fail­ure, ac­cord­ing to the com­mit­tee.

This move stems from the safe­ty com­mit­tees’ re­view of a clin­i­cal tri­al in­volv­ing pa­tients with HRS-1 which showed that those treat­ed with these med­i­cines were more like­ly to ex­pe­ri­ence and pos­si­bly die from repara­to­ry dis­or­ders with­in 90 days than those with a place­bo. How­ev­er, lim­i­ta­tions were not­ed in the da­ta in­clud­ing dif­fer­ences in how ter­li­pressin was used in the tri­als com­pared to the ac­tu­al clin­i­cal space. But com­bin­ing this with da­ta on hand con­vinced the PRAC to take new mea­sures.

The med­i­cines are avail­able in most EU mem­ber states un­der sev­er­al names in­clud­ing gly­pressin, ter­li­pressin ac­etate and variquel.

How­ev­er, that is not the on­ly med­i­cine that the EMA is rais­ing con­cerns about. It is al­so let­ting health­care providers know of an in­creased risk of se­ri­ous and dead­ly car­diac ar­rhyth­mias and car­diac fail­ure with the use of Im­bru­vi­ca.

While the drug from J&J and Ab­b­Vie is meant to treat peo­ple with blood can­cers, the EMA said that pa­tients with “ad­vanced age” may be at a greater risk of car­diac events that may be fa­tal.

The PRAC is ad­vis­ing that an eval­u­a­tion of car­diac his­to­ry should be con­duct­ed be­fore start­ing treat­ment. Pa­tients that are at risk should be as­sessed be­fore treat­ment starts and pos­si­ble al­ter­na­tives may be con­sid­ered and should not be giv­en to any­one with on­set or wors­en­ing of grade two car­diac fail­ure or grade three car­diac ar­rhyth­mias.

Bri­an Ken­ney

Bri­an Ken­ney, the glob­al ther­a­peu­tic area and cross-sec­tor on­col­o­gy com­mu­ni­ca­tion leader at Janssen R&D, said in an email to End­points News the com­pa­ny had re­cent­ly up­dat­ed the Im­bru­vi­ca Sm­PC to pro­vide fur­ther in­for­ma­tion for health­care pro­fes­sion­als about mon­i­tor­ing and man­ag­ing pa­tients with car­diac risks along with spe­cif­ic guid­ance re­lat­ed to dose mod­i­fi­ca­tions for pa­tients.

“We con­tin­u­al­ly mon­i­tor pa­tient safe­ty and, work­ing close­ly with the EMA, up­date our la­bel guid­ance ac­cord­ing­ly as ad­di­tion­al clin­i­cal tri­al da­ta and re­al-world ex­pe­ri­ence is ac­cu­mu­lat­ed. We are con­fi­dent in the ben­e­fit/risk pro­file of Im­bru­vi­ca, which has been used to treat more than 250,000 pa­tients world­wide with com­plex B-cell blood can­cers,” Ken­ney said in the email.

Im­bru­vi­ca is a ma­jor drug for J&J and Ab­b­Vie, when da­ta on the BTK in­hibitor was re­vealed at AS­CO in June, it kept a rare and ag­gres­sive form of can­cer back, in com­bi­na­tion with two oth­er drugs, for more than six years, how­ev­er, in­ves­ti­ga­tors did not see a sig­nif­i­cant dif­fer­ence in over­all sur­vival. Last month, it al­so won ap­proval in a pe­di­atric pop­u­la­tion as it net­ted ap­proval as a sec­ond-line treat­ment for chron­ic graft ver­sus host dis­ease (cGVHD) in chil­dren one year and old­er.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.