Regulatory

Roche scores an unusual ‘breakthrough’ at the FDA for an autism drug

The team at Roche’s Basel-based underdog R&D group pRED has something to cheer about today. The FDA has designated their autism drug RG7314 (balovaptan) as a “breakthrough” therapy worthy of VIP treatment at the agency.

John Reed

Overshadowed by Genentech (gRED) over the past 9 years, Roche $RHHBY has been pumping money into the Basel group for years, with little to show for it after a major restructuring that left John Reed in charge.

The FDA, though, says that balovaptan — a V1A vasopressin receptor antagonist — had offered enough human and animal data to demonstrate its potential for helping improve the social behavior of people with autism spectrum disorders.

Autism in general has been a hard target in drug R&D, one of many tough challenges in the neurosciences field, where Roche maintains a major commitment after many of its big pharma peers bowed out.

In its pipeline outline Roche says it expects to file for an approval sometime around 2020 or later. A breakthrough drug designation may help accelerate that process as regulators maintain their commitment to hurrying along drugs with great promise. Roche’s pRED, though, is not known for rapid development programs. This drug was in Phase II back in 2014, when Roche announced its latest setbacks in neurosciences with a failure for Fragile X.


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