Click Therapeutics' digital therapeutic (DTx) CT-132 has been approved by the FDA, becoming the first treatment of its type in the US for preventing attacks in people with episodic migraine.
The company said CT-132 can be prescribed for the preventive treatment of episodic migraine in patients 18 years of age and older and is intended for adjunctive use alongside drug-based treatments.
The approval is a boost for the DTx sector, which has seen a number of prescription therapies approved for marketing, but far fewer examples that have been commercially successful, in part because there is no dedicated, well-defined benefit category for these products in Medicare and Medicaid.
Some of the pioneers in the category – such as Pear Therapeutics and Better Therapeutics – were forced into administration after failing to build viable DTx businesses, while a wave of consolidation has also seen some players join forces to try to build stronger portfolios.
Click has participated in that M&A, picking up rights to Better's assets, including a prescription DTx in development for type 2 diabetes.
Its latest approval follows earlier green lights from the FDA for its Otsuka-partnered major depressive disorder (MDD) Rejoyn, and the AspyreRx app developed by Better, which was cleared in 2023.
It is based on the results of the 568-patient ReMMi-D trial, in which the mobile app achieved a statistically significant reduction in monthly migraine days after 12 weeks of treatment compared to a sham app when given on top of standard drug therapy such as triptans.
In the study, Click's DTx reduced the number of migraine days in a month by around three, roughly one day more than the control. To put that into context, episodic migraine is characterised by headaches that occur on fewer than 15 days per month. Above that level, patients are considered to have chronic migraine.
Click has also completed a second, smaller bridging study, called ReMMiD-C, which looked at patients on the newer class of CGRP inhibitors, and supported its application to the FDA.
"This marks a significant milestone for the more than 37 million adults in the US who live with migraine," commented Shaheen Lakhan, Click's chief medical and scientific officer.
"As a groundbreaking digital therapeutic for migraine prevention, CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients."
https://pharmaphorum.com/news/fda-clears-first-migraine-dtx-click-therapeutics
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