The FDA has typically used real-world evidence (RWE) as a way of monitoring safety issues post-approval, especially through the Sentinel Initiative, which started in response to the FDA Amendments Act of 2007.
“We’re surprised by this outright failure as well as the lack of an investor call to discuss the most significant development in the history of the company.”
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously concluded that Amarin Corp. plc provided sufficient evidence of efficacy and safety to support approval of fish oil-based Vascepa (icosapent ethyl).
Regulatory decisions affecting biopharma products in development, including approvals, recommendations, rejections and the granting of regulatory pathways in October 2019.
The annual American Heart Association's Scientific Sessions saw some significant findings, with the results of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial standing out in particular. Of note, investigators found no evidence that invasive procedures – such as stent implants or bypass surgery – in individuals with severe but stable heart disease had lower rates of major, disease-related events vs. those treated with medications and lifestyle changes alone, also known as optimal medical therapy (OMT).
Axonics Modulation Technologies Inc., of Irvine, Calif., reported revenue of $1.3 million for the third quarter of 2019, up from $0.2 million in the same period last year, but below Wall Street's forecast of $1.4 million. CEO Raymond Cohen attributed the miss to a seasonal slowdown in implants of Axonics' rechargeable sacral neuromodulation (r-SNM) system in international markets, as well as some U.S. physicians who were waiting for the device to win urinary approval. That milestone came Thursday when the U.S. FDA approved Axonics' r-SNM for the treatment of overactive bladder (OAB) and urinary retention. The indication for urinary retention represents the largest segment of the market for SNM devices and comes just two months after FDA approved the r-SNM to help patients with fecal incontinence. (See BioWorld MedTech, Sept. 10, 2019.)
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