FDA Approves Merck's Lipfendra, First Oral PCSK9 Drug to Match Injectables
New Delhi, July 17 -- a biweekly or monthly injection that most patients eventually abandon. Fear of needles accounts for some of that dropout. Cost and inconvenience account for more, and insurers have layered prior authorization requirements on top. The Food and Drug Administration moved Wednesday to give those patients a different path.
The agency approved enlicitide, sold under the brand name Lipfendra, an oral tablet from Merck that reduces LDL cholesterol by more than half in clinical trials, matching the performance of the injectable PCSK9 inhibitors that have defined the top tier of cholesterol treatment for a decade. It is the first pill of its class to reach that level of potency and the first oral PCSK9 inhibitor the agency ha...
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