Ingrezza label gives Neurocrine a competitive edge
It has been over 20 years in the making, but Neurocrine finally received US approval for its first product, Ingrezza, for treating tardive dyskinesia. Perhaps as important as the decision itself is that Ingrezza's label excludes any boxed warnings, giving it an advantage over Teva’s similar product, Austedo, recently approved in Huntington’s chorea.
Top of the list of unknowns, however, is Ingrezza's price, and this is not expected to be announced until the drug's launch in May. The company noted that it will be “competitively” priced and investors are eagerly watching for details; for now the markets are convinced, with Neurocrine's stock opening 24% higher this morning, pushing the company's market value to an incredible $4.6bn.
There is reason for optimism: Ingrezza has become the first FDA-approved treatment for adults with tardive dyskinesia, a movement disorder that is a serious side effect in patients who have been treated with antipsychotic medications for long periods of time. Ingrezza’s properties allow for concomitant dosing with existing psychiatric regimens.
Its label does note serious side effects, including sleepiness and heart rhythm problems, but importantly it does not require a black box warning against suicidality or depression.
The latter is included on Teva’s label for Austedo, another VMAT inhibitor filed under the 505(b)(2) pathway and recently approved for Huntington’s chorea. Austedo’s own FDA verdict in tardive dyskinesia is due in August (Teva delivers some good news as pressure builds, April 4, 2017).
Both Ingrezza and Austedo are altered versions of tetrabenazine, which is now available generically but was hampered by a strict REMS program.
While the cost at which Neurocrine will launch remains unknown it previously guided to an annual price of $20,000-$60,000 for its 40mg dose. Teva has implied that its tardive dyskinesia dose of 24mg will cost around $60,000 annually, so both look like they wil be coming below generic tetrabenazine at some $96,000.
Neurocrine plans to file a supplemental NDA for the 80mg capsule by the summer, and expects approval by the end of the year, saying it will set the same price for the two doses. Notably, the FDA has requested that the company also study higher doses in tardive dyskinesia to determine additional efficacy.
Few details were given on expected trials, but the company noted that it had previously looked at 100mg for two weeks. Meanwhile, phase II data in Tourette's disease are due in May.
EvaluatePharma consensus of sellside forecasts made before yesterday’s approval put 2022 Ingrezza sales in tardive dyskinesia at $656m, above Austedo’s $497m in the same indication. With its impressive label in the bag the numbers could now be due a revision.