UPDATED: AbbVie adds to the Botox war chest with a 12th FDA approval — but competition is fast approaching
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.