Allergan PLC has gotten regulatory approval for another use of Botox.
The company’s signature drug, best known for treating wrinkles, received FDA approval last month for the use of its famed neurotoxin in pediatric patients to treat lower limb spasticity—meaning increased muscle contraction that can cause stiffness in a child’s legs and interfere with movement.
“Lower limb spasticity can impact many aspects of a child’s life and have a drastic influence on their overall development and quality of life,” said David Nicholson, Allergan’s head of research and development.
“This milestone will continue to support and advance care for children and their caregivers who may be struggling with lower limb spasticity,” Nicholson said in a statement.
The FDA approval doesn’t apply to children with lower limb spasticity that is due to the effects of cerebral palsy.
French pharmaceutical company Ipsen SA has market exclusivity for its Botox-similar neurotoxin Dysport in those specific cases.
Allergan, however, has exclusive rights over the use of Botox to treat those same types of symptoms in the U.S. market—for the upper limbs. It got the FDA’s approval for those uses in June.
$3.6B Market
Botox accounted for $3.6 billion in annual sales for Allergan, which is being bought by AbbVie Inc. for $63 billion; the deal is expected to close during the first quarter of next year.
The neurotoxin first entered commercial markets in 1989 and has expanded its use for treatment in the decades since. Allergan’s Irvine campus, which while shrinking in size the past few years, still plays a large role in the development of Botox uses.
Botox is the most well-known neurotoxin, but it is not the only one on the market for aesthetics. A direct competitor is Newport Beach-based Evolus Inc. (Nasdaq: EOLS), which has a brand called Jeuveau that launched this past summer.
Evolus counts a $470 million market cap.
