Allergan Resubmits sBLA for Botox, Provides FDA With Additional Data

Allergan has resubmitted its sBLA for Botox, providing the FDA with additional study data on the effects of the injectable drug on lower limb spasticity.

The resubmission includes further data from a double-blind, placebo-controlled study involving 468 patients. The study showed that as early as week two, a single injection reduced post-stroke spasticity in the lower limbs. Allergan says the improvement in muscle tone was clinically meaningful, the drug was well-tolerated and no new safety signals were observed.

The FDA has assigned a six-month review period for the sBLA for treatment of ankle and toe muscles, putting the PDUFA date sometime in the first quarter of 2016, Allergan said last week.

In April, the FDA approved Botox (onabotulinumtoxinA) to treat increased stiffness in two thumb muscles, expanding a previous approval in 2010 for the elbow, wrist and fingers in patients 18 and older with upper limb spasticity. — Jonathon Shacat