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Intra-Cellular soars on FDA approval of schizophrenia drug

Shares rocketed following the announcement


US biotech Intra-Cellular Therapeutics has scored approval for its antipsychotic drug Caplyta for the treatment of schizophrenia, to the delight of investors. 

Shares in the company rocketed over 178% yesterday as the news broke, after the FDA approved Caplyta (lumateperone) as a treatment for schizophrenia in adults.

Caplyta is backed by two phase 3 trials in schizophrenia which showed that the drug can be administered at a fixed dose, and controlled psychotic symptoms with a safety profile similar to placebo.

While one of those trials was undermined by a high placebo response, there was clearly enough evidence to move forward with the programme and win an approval.

The drug is a dopamine receptor phosphoprotein modulator (DPPM) with selective action on dopamine D2 receptors, serotonin 5-HT2A receptors and dopamine D1 receptors.

Intra-Cellular has argued that this differentiates Caplyta from existing schizophrenia drugs, maintaining that it provides additional benefits such as improved psychosocial functioning.

“We believe Caplyta provides healthcare providers a new, safe and effective treatment option to help the millions of adult patients with schizophrenia,” said Sharon Mates, chairman and CEO of Intra-Cellular.

“This approval represents the culmination of years of scientific research. We are especially grateful to the patients, their caregivers and the healthcare professionals who have contributed to the development of Caplyta,” she added.

Intra-Cellular will now need to convince prescribers of the benefits of its drug if it wants to see it make significant sales growth. The schizophrenia market is crowded and highly genericised, so making a strong case for the drug’s superiority will be essential.

The approval is an early Christmas present for Intra-Cellular, especially given the mixed opinions on Caplyta's chances of approval.

There had been previous concerns regarding safety issues seen in earlier animals studies, although the company has said that animals and humans metabolize the drug differently, so these issues wouldn’t apply to humans.

Stifel analyst Paul Matteis has said that the approval of Intra-Cellular is good news for other companies looking for approval of central nervous system therapies. This includes Sage Therapeutics, Acadia Pharmaceutical, Karuna Therapeutics and even Biogen, which is looking for approval of its controversial Alzheimer’s drug.

According to Matteis, the Caplyta approval indicates that regulators will “often look at a mixed efficacy package in CNS through a 'glass half full lens'," due to the increased need for new therapies in these areas that are significantly lacking treatment options.

Article by
Lucy Parsons

24th December 2019

From: Regulatory



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