Com­pe­ti­tion is clos­ing in on Ab­b­Vie’s block­buster Botox fran­chise — de­spite the drug­mak­er’s best ef­forts to avoid it. In the mean­time, the Chica­go area drug gi­ant can take some so­lace in a new in­di­ca­tion that will add to the block­buster drug’s war chest.

The FDA on Wednes­day gave Botox the green light to treat de­tru­sor (blad­der mus­cle) over­ac­tiv­i­ty as­so­ci­at­ed with neu­ro­log­i­cal con­di­tions in chil­dren 5 and old­er who were in­tol­er­ant to or didn’t im­prove on an­ti­cholin­er­gic meds, Ab­b­Vie said in a state­ment. Botox is now the first neu­ro­tox­in ap­proved for such use, the drug­mak­er said.

“While al­ways sat­is­fy­ing to bring forth new in­di­ca­tions, it is par­tic­u­lar­ly re­ward­ing when we can help ad­vance care for pe­di­atric pa­tients,” Mitchell Brin, Ab­b­Vie’s se­nior VP and CSO of Botox and neu­ro­tox­ins, said in a state­ment.

Blad­der mus­cle over­ac­tiv­i­ty oc­curs when the spinal cord and blad­der can’t com­mu­ni­cate ef­fec­tive­ly, caus­ing the blad­der mus­cle to in­vol­un­tar­i­ly con­tract. This in­creas­es pres­sure in the blad­der and re­duces blad­der ca­pac­i­ty, which can cause pa­tients to leak urine and suf­fer blad­der and kid­ney dam­age over time. In chil­dren, the most com­mon neu­ro­log­i­cal cause is spina bi­fi­da, though it can al­so be spurred by con­di­tions like trans­verse myelitis and spinal cord in­jury.

“When car­ing for pe­di­atric pa­tients with neu­ro­genic de­tru­sor over­ac­tiv­i­ty, we strive to re­duce blad­der pres­sure and in­crease the blad­der’s ca­pac­i­ty. Pre­vi­ous­ly, treat­ment op­tions were lim­it­ed pri­mar­i­ly to an­ti­cholin­er­gic med­i­cines, where long-term use needs to be con­sid­ered care­ful­ly, in ad­di­tion to surgery,” said Paul Austin, chief of pe­di­atric urol­o­gy at Texas Chil­dren’s Hos­pi­tal and pro­fes­sor of urol­o­gy at Bay­lor Col­lege of Med­i­cine.

Ab­b­Vie sub­mit­ted a sup­ple­men­tal BLA for the con­di­tion back in June, and said it ex­pect­ed a de­ci­sion by Q1 2021. Right on time, the OK was based on a Phase III study with more than 100 chil­dren, which showed that Botox re­duced day­time uri­nary in­con­ti­nence episodes, low­ered max­i­mum blad­der pres­sure and in­creased blad­der ca­pac­i­ty af­ter six weeks.

The most com­mon ad­verse re­ac­tions were bac­teri­uria (20%), uri­nary tract in­fec­tion (7%), leuko­cy­turia (7%), and hema­turia (3%), ac­cord­ing to Ab­b­Vie.

Al­ler­gan snagged its first ap­proval for Botox back in 1989 for two rare eye mus­cle dis­or­ders — ble­pharospasm and stra­bis­mus — then stacked on a va­ri­ety of oth­er in­di­ca­tions, in­clud­ing chron­ic mi­graine, over­ac­tive blad­der, cer­vi­cal dys­to­nia, spas­tic­i­ty and se­vere un­der­arm sweat­ing.

The fran­chise be­came Ab­b­Vie’s in 2019 when it sealed a $63 bil­lion deal to buy out Al­ler­gan. Ab­b­Vie im­me­di­ate­ly carved off Botox’s cos­met­ic use and Al­ler­gans’ oth­er cos­met­ic port­fo­lio in­to an Al­ler­gan Aes­thet­ics sub­sidiary and kept the drug’s ther­a­peu­tic in­di­ca­tions un­der the larg­er com­pa­ny’s di­rect um­brel­la.

Al­ler­gan has put up a tough fight against Botox com­peti­tors, in­clud­ing Evo­lus, which Al­ler­gan took to court on al­le­ga­tions that its Jeu­veau was de­vel­oped us­ing a stolen trade se­cret. In De­cem­ber, Evo­lus was is­sued a 21-month ban on the im­por­ta­tion or sale of the wrin­kle treat­ment — which was re­duced from an ini­tial 10-year ban pro­posed by a judge, Bloomberg re­port­ed. 

Still, oth­er ri­vals are cir­cling in on Botox, in­clud­ing Re­vance, which read out pos­i­tive Phase III re­sults for its Dax­i­bot­u­linum­tox­i­nA in Oc­to­ber. The FDA de­ferred its de­ci­sion on Re­vance’s BLA in No­vem­ber due to Covid-re­lat­ed trav­el re­stric­tions that kept the agency from per­form­ing an in­spec­tion of the com­pa­ny’s man­u­fac­tur­ing fa­cil­i­ty. And In June, Re­vance and My­lan an­nounced plans to move for­ward with a sep­a­rate pro­gram for a Botox biosim­i­lar.

Botox raked in $991.3 mil­lion in net sales in 2019, a 9.3% in­crease from 2018.

This sto­ry has been up­dat­ed to add that the new in­di­ca­tion in­cludes chil­dren who are in­tol­er­ant to an­ti­cholin­er­gic meds. 

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.