Allergan: Receives FDA Approval for Juvederm

Allergan, Inc. (AGN) received good news recently in the form of US Food and Drug Administration (FDA) approval for a new version of the company’s dermal filler, Juvederm. The FDA granted approval to Juvederm XC, which is the latest version of the company’s Juvederm family of products that consists of Juvederm Ultra and Juvederm Ultra Plus.

Juvederm XC should see significant uptake among physicians and patients. It contains lidocaine, a local anesthetic. This gives patients additional comfort while receiving treatment for moderate to severe facial wrinkles and folds. The treatment area becomes numb within seconds of the product being administered. This helps reduce the need for additional anesthetics and also cuts down on the time spent in the doctor’s office. Earlier, it took up to 30 minutes for an anesthetic to take effect. We believe users will switch rapidly to the new product, which will be available immediately.

Juvederm XC’s approval was based on data from a multi-center, double-blind, randomized clinical trial which was conducted with 72 patients. Results showed that 93% of the patients experienced less pain when treated with Juvederm XC compared to patients receiving the non-lidocaine formulation of Juvederm. Moreover, the product was found to be more effective in reducing procedural pain while maintaining a similar safety and effectiveness profile as the non-lidocaine formulation.

Allergan’s dermal filler franchise has been under pressure over the past few quarters mainly due to weak consumer spending. Moreover, the company faces significant competition from players like Johnson & Johnson (JNJ - Analyst Report) and Medicis (MRX - Snapshot Report).

However, performance of this segment should improve with the new product approval and increased direct to consumer (DTC) efforts by Allergan. We currently have a Neutral recommendation on Allergan.