FDA sup­ports lim­it­ed dis­tri­b­u­tion of an­ti­smok­ing drug Chan­tix de­spite car­cino­gen risk

Ear­li­er this month, the FDA alert­ed the pub­lic that Pfiz­er had vol­un­tar­i­ly re­called its stop-smok­ing drug Chan­tix af­ter find­ing el­e­vat­ed lev­els of can­cer-caus­ing ni­trosamines. Now, the FDA is per­mit­ting cer­tain man­u­fac­tur­ers to tem­porar­i­ly dis­trib­ute the drug that has more than the usu­al ni­trosamine, so long as it re­mains un­der the in­ter­im ac­cept­able lim­it.

Pfiz­er pre­vi­ous­ly halt­ed dis­tri­b­u­tion of Chan­tix and pulled four lots of the drug af­ter find­ing un­ac­cept­ably high lev­els of the ni­trosamine N-ni­troso-vareni­cline in rou­tine test­ing. In guid­ance re­leased Fri­day, the FDA set an in­ter­im al­low­able lim­it for that com­pound in Chan­tix at 185 ng per mil­li­liter to help en­sure ad­e­quate sup­ply of the drug in the US.

“Agency sci­en­tists eval­u­at­ed the risk of ex­po­sure to N-ni­troso-vareni­cline at in­ter­im ac­cept­able in­take lev­els up to 185 ng per day and de­ter­mined that it presents min­i­mal ad­di­tion­al can­cer risk when com­pared to a life­time of ex­po­sure to N-ni­troso-vareni­cline at the 37 ng per day lev­el,” the FDA said in a press re­lease Fri­day.

The FDA called for pa­tients to con­tin­ue to take the med­ica­tion un­til their doc­tor pre­scribes an an al­ter­na­tive: “The health ben­e­fits of stop­ping smok­ing out­weigh the can­cer risk from the ni­trosamine im­pu­ri­ty in vareni­cline,” the re­lease said.

The re­call came just a year af­ter the FDA found high lev­els of ND­MA, an­oth­er com­mon ni­trosamine, in some ver­sions of met­formin, a pop­u­lar gener­ic di­a­betes drug. Viona Phar­ma­ceu­ti­cals was the lat­est gener­ic man­u­fac­tur­er to pull its ver­sion off shelves, re­call­ing two lots of its 750 mg ex­tend­ed-re­lease met­formin tablets in June.

Mon­day, three more lots were re­called: ET1600, with an ex­pi­ra­tion date of Jan­u­ary 2023, and both EA6080 and EC9843 with an ex­pi­ra­tion date of March 2023.

That marked the fourth ver­sion of the drug since No­vem­ber 2020 to be re­called due to re­ports of ND­MA,  which was al­so im­pli­cat­ed in re­calls of blood pres­sure drug val­sar­tan and heart­burn med Zan­tac.

Chan­tix was first ap­proved by the FDA in 2006 and is used as a pre­scrip­tion in adults who need help quit­ting smok­ing. The drug­mak­er said it is paus­ing the dis­tri­b­u­tion “out of an abun­dance of cau­tion.”

The drug is ap­proved in 80 coun­tries, but re­call no­tices have been gen­er­at­ed by Cana­di­an and Ko­re­an reg­u­la­tors. In Ko­rea, the min­istry of food and drug safe­ty has been in­ves­ti­gat­ing an­ti-nico­tine ther­a­pies that use vareni­cline as its main com­pound since June 15, ac­cord­ing to the Ko­rea Bio­med­ical Re­view.

Pfiz­er will have to test for ni­trosamine im­pu­ri­ties in all drugs that con­tain vareni­cline. The FDA has not yet list­ed the drug on the re­call por­tion of its web­site.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.