FDA adds Guil­lain-Bar­ré syn­drome warn­ing to Glax­o­SmithK­line’s shin­gles vac­cine

The FDA late Wednes­day sent out a safe­ty com­mu­ni­ca­tion to ex­plain that while Glax­o­SmithK­line’s shin­gles vac­cine Shin­grix is a safe vac­cine, it’s now added a new warn­ing to the la­bel not­ing an in­creased risk of a rare but de­bil­i­tat­ing dis­or­der known as Guil­lain-Bar­ré syn­drome (GBS).

“In a post­mar­ket­ing ob­ser­va­tion­al study, an in­creased risk of GBS was ob­served dur­ing the 42 days fol­low­ing vac­ci­na­tion with Shin­grix,” the up­dat­ed Warn­ings and Pre­cau­tions sec­tion of the la­bel now says. The FDA al­so de­ter­mined that the ben­e­fits of vac­ci­na­tion with Shin­grix con­tin­ue to out­weigh its risks.

The FDA said in its safe­ty com­mu­ni­ca­tion that it found the risk by comb­ing through Medicare claims da­ta from more than 3.7 mil­lion vac­ci­na­tions with Shin­grix be­tween Oc­to­ber 2017 and Feb­ru­ary 2020.

“The pri­ma­ry analy­sis (claims-based, all dos­es) found an in­creased risk of GBS dur­ing the 42 days fol­low­ing vac­ci­na­tion with Shin­grix, with an es­ti­mat­ed 3 ex­cess cas­es of GBS per mil­lion dos­es ad­min­is­tered to adults aged 65 years or old­er,” FDA said. “In sec­ondary analy­ses, an in­creased risk of GBS was ob­served dur­ing the 42 days fol­low­ing the first dose of Shin­grix, with an es­ti­mat­ed 6 ex­cess cas­es of GBS per mil­lion dos­es ad­min­is­tered to adults aged 65 years or old­er, and no in­creased risk of GBS was ob­served fol­low­ing the sec­ond dose of Shin­grix.”

Each year in the US, an es­ti­mat­ed 3,000 to 6,000 peo­ple de­vel­op GBS, FDA said, which is about 10 to 20 cas­es of GBS per mil­lion peo­ple each year.

The FDA al­so ac­knowl­edged that it did not iden­ti­fy an in­creased risk for GBS in its eval­u­a­tion of the clin­i­cal tri­als da­ta for Shin­grix, which the agency eval­u­at­ed pri­or to the vac­cine’s ap­proval in 2017.

“Rare ad­verse events, some of which may be se­ri­ous, may be­come ap­par­ent with more wide­spread use of the vac­cine,” the agency said.

GSK told End­points News in a state­ment, “GSK re­mains con­fi­dent in the fa­vor­able ben­e­fit-risk pro­file of SHIN­GRIX for the pre­ven­tion of shin­gles. We will con­tin­ue to com­mu­ni­cate with FDA and CDC on post-mar­ket­ing safe­ty mon­i­tor­ing for SHIN­GRIX.”

The state­ment al­so not­ed that at the Feb­ru­ary 2021 meet­ing of the CDC Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, the Her­pes Zoster Work Group pre­sent­ed re­sults of a com­pre­hen­sive risk-ben­e­fit analy­sis of Shin­grix that in­clud­ed a re­view of post-mar­ket­ing da­ta. “The analy­sis con­clud­ed: GBS is rare, and da­ta on the risk of GBS fol­low­ing HZ (her­pes zoster or ‘shin­gles’) and vac­ci­na­tion are lim­it­ed. Clin­i­cal tri­als, ob­ser­va­tion­al stud­ies and the risk-ben­e­fit analy­sis con­firm the con­sid­er­able ben­e­fits of RZV (SHIN­GRIX) vac­ci­na­tion in pre­vent­ing HZ, se­vere dis­ease and com­pli­ca­tions.”

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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