EMA finds link be­tween ‘very rare’ but some­times fa­tal blood clots and As­traZeneca vac­cine

The EMA said Wednes­day that very rare but some­times fa­tal blood clots should be list­ed as a side ef­fect for As­traZeneca’s Covid-19 vac­cine.

The EMA’s safe­ty com­mit­tee said the change to the vac­cine la­bel is part of an in-depth re­view of 62 cas­es of cere­bral ve­nous si­nus throm­bo­sis (CVST) and 24 cas­es of splanch­nic vein throm­bo­sis re­port­ed in the EU drug safe­ty data­base as of March 22. Eigh­teen of the cas­es were fa­tal.

De­spite the rare side ef­fects for the vac­cine, known as Vaxzevria, EMA ex­ec­u­tive di­rec­tor Emer Cooke said in a press con­fer­ence on Wednes­day that the ben­e­fits of the vac­cine still out­weigh the risks.

“The risk of mor­tal­i­ty from Covid is much greater than the risk of mor­tal­i­ty from these side ef­fects,” Cooke said.

The safe­ty com­mit­tee said it can­not make any rec­om­men­da­tions to re­duce the risk of the rare side ef­fects. Sabine Straus, chair of the EMA’s Phar­ma­covig­i­lance Risk As­sess­ment Com­mit­tee, said the re­port­ed rate of CVST is be­tween 1 and 2 per 100,000 peo­ple.

“One plau­si­ble ex­pla­na­tion for the com­bi­na­tion of blood clots and low blood platelets is an im­mune re­sponse, lead­ing to a con­di­tion sim­i­lar to one seen some­times in pa­tients treat­ed with he­parin,” EMA said.

As of April 4, EMA said a to­tal of 169 cas­es of CVST and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed to the data­base, among 34 mil­lion peo­ple who have been vac­ci­nat­ed with in the EEA and UK. By com­par­i­son, Straus not­ed that for the J&J vac­cine, 3 CVST cas­es were found among 4.5 mil­lion vac­ci­nat­ed in the EU/EEA, for Pfiz­er, 35 CVST cas­es world­wide were found and 54 mil­lion re­ceived the vac­cine in the EEA, and for Mod­er­na, 5 CVST cas­es world­wide were among 4 mil­lion vac­ci­nat­ed in the EEA.

“EMA is re­mind­ing health­care pro­fes­sion­als and peo­ple re­ceiv­ing the vac­cine to re­main aware of the pos­si­bil­i­ty of very rare cas­es of blood clots com­bined with low lev­els of blood platelets oc­cur­ring with­in 2 weeks of vac­ci­na­tion. So far, most of the cas­es re­port­ed have oc­curred in women un­der 60 years of age with­in 2 weeks of vac­ci­na­tion. Based on the cur­rent­ly avail­able ev­i­dence, spe­cif­ic risk fac­tors have not been con­firmed,” the agency said.

Sep­a­rate­ly on Wednes­day, the UK’s med­i­cines reg­u­la­tor MHRA an­nounced that those un­der the age of 30 should not re­ceive the As­traZeneca vac­cine. As of March 31, 20.2 mil­lion dos­es of the As­traZeneca vac­cine had been ad­min­is­tered in the UK, mean­ing the over­all risk of these blood clots is ap­prox­i­mate­ly 4 peo­ple in a mil­lion who re­ceive the vac­cine, the MHRA said.

As­traZeneca said in a state­ment that it “has been ac­tive­ly col­lab­o­rat­ing with the reg­u­la­tors to im­ple­ment these changes to the prod­uct in­for­ma­tion and is al­ready work­ing to un­der­stand the in­di­vid­ual cas­es, epi­demi­ol­o­gy and pos­si­ble mech­a­nisms that could ex­plain these ex­treme­ly rare events.”

The World Health Or­ga­ni­za­tion added in a state­ment, “Based on cur­rent in­for­ma­tion, a causal re­la­tion­ship be­tween the vac­cine and the oc­cur­rence of blood clots with low platelets is con­sid­ered plau­si­ble but is not con­firmed. Spe­cialised stud­ies are need­ed to ful­ly un­der­stand the po­ten­tial re­la­tion­ship be­tween vac­ci­na­tion and pos­si­ble risk fac­tors.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.