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.”

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pillar drugs of Sanofi’s $11.6 billion pickup of Bioverativ hit a big setback late last year when the FDA sent its application for approval back. Now, as Sanofi gears up to resubmit the drug for review, the drugmaker is touting pivotal data it hopes will help take it over the finish line.

Sanofi’s sutimlimab nailed all three of its primary endpoints in its Phase III CADENZA study for patients with cold agglutinin disease, a rare disorder that can cause severe anemia, without a recent history of blood transfusion, the French drugmaker said Friday. The topline results will be presented at this weekend’s virtual EHA meeting.

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An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.