Breaking Ground: FDA Grants Breakthrough Designation for PWS Drug Development

Big news! Soleno Therapeutics has announced a groundbreaking achievement: diazoxide choline (DCCR) has been granted Breakthrough Therapy Designation by the FDA for Prader-Willi syndrome (PWS). This marks a significant milestone as the FIRST-EVER designation for a drug developed for PWS.

The designation underscores the FDA’s recognition of PWS as a serious condition and the potential for DCCR to offer substantial improvement for patients with hyperphagia. While this is a major step forward, it’s important to note that DCCR’s approval is still pending. However, Soleno plans to submit its New Drug Application in mid-2024.

To help ensure the FDA pays attention to this NDA, we encourage our community to sign the petition by May 23rd here:

Read Soleno’s full press release announcement at the button below.

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