Bladder Pain Syndrome: US FDA Outlines A Different Approach To Personalized Medicine
US FDA is following through on defining interstitial cystitis and bladder pain syndrome as a single condition – a move that runs counter to the trend towards more targeted, mechanistic definitions of disease. But the agency also offers a unique idea for endpoints that are truly personalized.
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US FDA advisory committee recommendation to combine interstitial cystitis and bladder pain syndrome patients in clinical trials is an interesting example of encouraging drug development by broadening the patient population. That runs counter to the personalized medicine mantra of narrowing patient populations based on mechanism of action.
Patients with the conditions experience the same symptoms, US FDA advisory committee concludes. Industry sponsors had advocated for combined trials, but panel did not agree with firms' recommendations on study duration and outcome measures.
Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.