FDA ex­pert pan­el lines up 19-to-1 against Pfiz­er’s os­teoarthri­tis drug tanezum­ab

Ed­ward Cheng

Out­side ex­perts ad­vis­ing the FDA vot­ed 19 to 1 against Pfiz­er’s po­ten­tial os­teoarthri­tis drug tanezum­ab, say­ing the pro­posed risk eval­u­a­tion and mit­i­ga­tion strat­e­gy (REMS) will not en­sure the ben­e­fits of the drug out­weigh the risks. One of the two con­sumer reps vot­ed yes.

Two dif­fer­ent FDA ad­vi­so­ry com­mit­tees on arthri­tis and drug safe­ty came to­geth­er over the last day and a half to re­view Pfiz­er’s drug, with pan­elists rais­ing se­ri­ous con­cerns about the safe­ty of the drug and how ef­fec­tive it is.

Ed­ward Cheng, pro­fes­sor of re­con­struc­tive surgery at the Uni­ver­si­ty of Min­neso­ta, said tanezum­ab “does not fill” the un­met need for an ef­fec­tive drug for os­teoarthri­tis and chron­ic arthri­tis pain, ex­plain­ing that it’s no bet­ter than as­pirin or ibupro­fen, or even place­bo.

Lewis Nel­son

Oth­er pan­elists raised con­cerns about Pfiz­er’s pro­posed REMS, echo­ing what the FDA said in its brief­ing doc­u­ments about how a REMS might not pre­vent or halt the progress of joint-re­lat­ed risks. Some pan­elists al­so raised con­cerns about un­known long-term risks and how it’s im­pos­si­ble to un­der­stand if a giv­en pa­tient will be at risk be­fore tak­ing the treat­ment.

Pan­elist Lewis Nel­son, chief of the di­vi­sion of med­ical tox­i­col­o­gy at Rut­gers New Jer­sey Med­ical School, said, “I have se­ri­ous con­cerns with the pro­posed REMS be­ing ef­fec­tive…We don’t know what hap­pens be­hind closed doors, and even iron-clad REMS with strict guardrails have failed. And this one is a lit­tle bit loos­er than those.”

Steven Meisel

Mem­bers of the com­mit­tees al­so raised mul­ti­ple con­cerns be­cause the drug may be used for many years. The long-term ef­fects of the drug “should not be dis­missed, even if you stop it,” added pan­elist Steven Meisel, sys­tem di­rec­tor of med­ica­tion safe­ty at Fairview Health Ser­vices.

And al­though Pfiz­er has been de­vel­op­ing tanezum­ab for more than 15 years, across 41 clin­i­cal stud­ies, mul­ti­ple pan­elists sought fur­ther in­for­ma­tion on long-term fol­low-up.

Jasvin­der Singh, com­mit­tee mem­ber and pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Al­aba­ma at Birm­ing­ham, called for a longer-term study with much larg­er sam­ples, and there would have to be ad­di­tion­al in­sights with re­gards to the un­der­stand­ing of the patho­phys­i­ol­o­gy and bi­ol­o­gy of what leads to this rapid­ly pro­gress­ing os­teoarthri­tis, which the REMS is meant to help mit­i­gate.

Com­mit­tee pan­elist Karim An­ton Calis, di­rec­tor of clin­i­cal re­search and com­pli­ance of­fice at the NIH, added, “We’re miss­ing in­for­ma­tion on long-term fol­low-up, and I don’t think it’s un­rea­son­able to ask for a fol­low-up study…I wish that had been done.”

Jim Rus­nak, chief de­vel­op­ment of­fi­cer of in­ter­nal med­i­cine at Pfiz­er, told End­points News in an emailed state­ment, “While we are dis­ap­point­ed in to­day’s out­come, we con­tin­ue to be­lieve that the clin­i­cal da­ta pre­sent­ed for tanezum­ab sup­ports its ben­e­fit-risk pro­file. The pa­tients whom we aim to help with tanezum­ab are suf­fer­ing from sig­nif­i­cant, de­bil­i­tat­ing os­teoarthri­tis pain and have ex­haust­ed avail­able med­ical ther­a­pies and are hope­ful for new, non-opi­oid treat­ments. We will con­tin­ue to work with the FDA to de­ter­mine next steps.”

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.