Allergan, Richter prep for FDA OK with positive PhIII for cariprazine in bipolar depression
Allergan $AGN and its partner Gedeon Richter came out this morning with some affirming Phase III data of its drug cariprazine, setting the duo on track for an add-on FDA OK that could mean big money for the partners.
The drug, already approved under the brand name Vraylar for schizophrenia and manic episodes, was tested in patients with depressive episodes associated with bipolar 1 disorder. During the trial, called RGH-MD-53, 493 patients were given either a 1.5 mg dose of cariprazine, a 3 mg dose, or placebo. For the patients on the smaller dose, secondary and primary endpoints were met, showing a significantly greater improvement than placebo for the change from baseline to week 6 on both the primary efficacy parameter, the Montgomery-Asberg Depression Rating Scale (p=0.0417), and the key secondary parameter, Clinical Global Impression Scale-Severity (p=0.0417).
After racking up a late-stage failure last year for bipolar patients, the companies’ researchers remained doggedly determined to stick it out. Now they plan to hustle an application to the FDA in search of a potentially big new approval. Gedeon Richter is on record saying this drug could generate up to $2 billion in annual revenue. Some analysts, though, have much more modest expectations around $200 million. And that was further underscored by the FDA’s recent decision to kick back an application for an added indication in schizophrenia with a refuse-to-file letter.
The companies also noted that the drug’s efficacy in bipolar 1 depression was demonstrated in three positive pivotal trials: this recent one, and RGH-MD-54 and RGH-MD56. Allergan said it plans to include data from all three pivotal trials in its supplemental new drug application or sNDA to the FDA in the second half of 2018.
“We are very pleased with the results of our third pivotal study, which reinforce the wealth of data supporting cariprazine as a potential treatment in adults with bipolar depression” said David Nicholson, R&D chief at Allergan, in a statement. “Bipolar depression is often difficult to treat and can be extremely debilitating for patients. At Allergan, we are committed to developing treatments that address unmet needs facing people living with mental illness and are looking forward to submitting an sNDA for cariprazine for patients suffering with bipolar I depression.”