Allergan and Gedeon Richter ready to knock on FDA's door after a positive PhIII for cariprazine in bipolar depression
Cariprazine is now 1 and 1 in Phase III bipolar depression studies. And the researchers involved say that should be good enough for a green light from regulators.
After racking up a late-stage failure last year for bipolar patients, researchers for Allergan $AGN and its partners at Gedeon Richter remained doggedly determined to stick it out. And in their second Phase III study the partners say they came up with solidly positive results — though the actual numbers were held back from the release.
Now they plan to hustle an application to the FDA in search of a potentially big new approval, laying claim to more positive data from an earlier Phase IIb trial that they plan to ship to regulators in their package of data.
FDA guidelines allow for an approval with statistical significance in two trials.
As the companies have remarked before, depression studies often run hit or miss, underscoring the poor track record on efficacy for a whole generation of depression drugs now in use.
Gedeon Richter is on record saying this drug — already initially approved as Vraylar for schizophrenia — 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.
Researchers tracked a positive change from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) total score for both doses used in the latest cariprazine trial.
“There are a limited number of products approved to treat bipolar depression and even fewer products that have been studied and approved to treat the full spectrum of bipolar disorder, from mania through depression. Having another product proven to treat the full range of bipolar disorder would be a welcome addition to the treatment options currently available to the psychiatry community and patients,” said Harvard Medical School’s Gary Sachs.