Glax­o­SmithK­line scores a win in Zofran case af­ter FDA re­peat­ed­ly said preg­nan­cy risk da­ta did not re­quire la­bel changes

GSK did suf­fi­cient­ly warn the FDA re­gard­ing birth de­fects tied to its nau­sea drug Zofran (on­dansetron), and be­cause the FDA de­cid­ed not to up­date the drug’s la­bel, GSK won a pos­i­tive de­ci­sion in a close­ly-watched case from the US Dis­trict Court of Mass­a­chu­setts on Tues­day.

The de­ci­sion makes clear that GSK and No­var­tis (the cur­rent own­er of Zofran as of 2015) in­formed the FDA of the avail­able da­ta on the safe­ty of Zofran, but from about 2010 un­til ear­li­er this year, the FDA re­ject­ed any la­bel changes that would’ve warned that us­ing the drug dur­ing preg­nan­cy could cause harm to the fe­tus. The CDC cur­rent­ly runs a web­site not­ing that, “Tak­ing On­dansetron Dur­ing Preg­nan­cy Does Not Ap­pear to In­crease Risk For Birth De­fects.”

The more than 400 law­suits filed in the mul­ti-dis­trict case against GSK claimed that the com­pa­ny with­held cru­cial da­ta that would’ve pushed the FDA to al­low the la­bel up­dates on Zofran.

F. Den­nis Say­lor

But Judge F. Den­nis Say­lor made clear in his de­ci­sion, “In short, even as­sum­ing that GSK did, in fact, fail to make com­plete dis­clo­sures to the FDA in 1991 [when Zofran’s ini­tial ap­proval oc­curred], and at var­i­ous lat­er points, there is no ques­tion that the FDA is now ful­ly in­formed of all rel­e­vant in­for­ma­tion con­cern­ing the safe­ty of the drug. And the FDA has made the de­ter­mi­na­tion that a la­bel change is not war­rant­ed.”

“Thus, the FDA, act­ing pur­suant to the du­ty im­posed on it by fed­er­al law, has re­ject­ed the preg­nan­cy warn­ing la­bel that plain­tiffs in­sist was re­quired by state law at the time of the al­leged in­juries. Ac­cord­ing­ly, and for the fol­low­ing rea­sons, plain­tiffs’ state-law claims of fail­ure to warn are pre­empt­ed by fed­er­al law,” he wrote.

GSK said in an emailed state­ment that it is pleased with the judge’s rul­ing in the com­pa­ny’s fa­vor, not­ing the court found that the FDA was ful­ly in­formed about the safe­ty pro­file of Zofran when it de­clined to add warn­ings to its la­bel.

The de­ci­sion may of­fer fur­ther clar­i­ty on whether the FDA’s la­bel­ing de­ci­sions pre­empt state law, which has been a bat­tle for the bio­phar­ma in­dus­try for years.

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.