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.

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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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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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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.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

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.