UCB's Epilepsy Drug Vimpat's Label Expanded in the U.S.

UCB’s (UCBJF) Vimpat has been approved in the U.S. as monotherapy for the treatment of partial-onset seizures in epilepsy patients aged 17 years and above.

Vimpat is already approved in the U.S. as an adjunctive therapy for partial-onset seizures in patients (≥17 years).

According to the press release issued by UCB, epilepsy affects more than 2 million people in the U.S. and 65 million people across the world. It is the fourth most common neurological disorder in the U.S.

With the approval of the supplemental new drug application (sNDA) for Vimpat, the drug’s label now covers three treatment options in the U.S. − initial monotherapy, conversion to Vimpat monotherapy and adjunctive therapy. This implies that apart from adjunctive treatment with Vimpat for partial-onset seizures, patients undergoing treatment with other anti-epileptic drugs can be switched to Vimpat monotherapy while new patients can also initiate treatment with Vimpat as monotherapy, for this indication.

Additionally, UCB announced that the FDA has approved a new single-loading dose administration option for all formulations of Vimpat. This will provide physicians an alternative option to the standard titration treatment with Vimpat.

In the EU, Vimpat is approved as an adjunctive therapy for the treatment of partial-onset seizures (with or without secondary generalization) in patients (16 years − 18 years) suffering from epilepsy. The single-loading dose administration option for Vimpat is approved in the EU as well.

Currently, UCB is studying Vimpat as monotherapy for partial-onset seizures in the EU in newly or relatively newly diagnosed patients aged ≥16 years.

Our Take

We are encouraged by the label expansion of Vimpat as it will increase the number of eligible patients for the drug and hence its revenues. In the first half of 2014, Vimpat achieved sales of €217 million, reflecting growth of 21% (at constant exchange rates) year over year.

UCB carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma sector include Endo International plc (ENDP), Lannett Company, Inc. (LCI) and Allergan Inc. (AGN). All these stocks carry a Zacks Rank #1 (Strong Buy).

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