Praluent Injection Receives FDA Approval to Treat High Cholesterol
Regeneron`s Biologic Praluent (alirocumab) Receives Approval in the U.S.
While Amgen and Regeneron’s spat before the Supreme Court goes forward on Amgen’s request to revive patents on its blockbuster Repatha and block the sale of Sanofi and Regeneron’s Praluent, another case is moving forward in federal court — this time Regeneron is pushing a case against Amgen and focusing on antitrust law.
Subcutaneous administration of the PCSK9 inhibitor, alirocumab, twice weekly alongside a statin to patients who received urgent percutaneous coronary intervention (PCI) after an acute myocardial infarction (MI), led to changes consistent with more stable non-infarct-related coronary arteries after 52 weeks. This was the conclusion of a randomised, placebo-controlled clinical trial by teams from Switzerland and Denmark.
On Monday, SCOTUS invited the solicitor general to file a brief expressing the views of the US on the patent case involving Amgen’s cholesterol drug Repatha as the court considers whether to hear the appeal of a ruling that invalidated Amgen’s patents for the drug.
Innovent Biologics is ready to make its play for the Chinese PCSK9 inhibitor market. Having racked up another two phase 3 wins, Innovent is preparing to file for an approval that would position it as a rival to Amgen’s Repatha and Sanofi’s Praluent in China.
As a class of drugs to treat high cholesterol, PCSK9 inhibitors have had trouble gaining tracking in the marketplace. Designed to treat people with high cholesterol who don’t respond to statins, since about 2015 a number of companies have received approval for these drugs but struggled with sales. They include Amgen’s Repatha, Sanofi and Regeneron’s Praluent, Novartis’s Leqvio, and Esperion’s Nexletol and Nexlizet.
The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.
On Friday, Repatha gained another edge with an FDA approval for pediatric patients 10 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce bad cholesterol. The nod is for Repatha to be used as an add-on treatment to diet modification and statins.
As we previously reported, in April 2021, Amgen petitioned for the full Federal Circuit to reconsider the decision of a three-judge panel that two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab), were invalid for failing to comply with the enablement requirement. In its petition, Amgen argued that the Federal Circuit panel improperly established a new standard for enablement of “genus claims with functional limitations” and that the Federal Circuit’s treatment of enablement as a legal issue, rather than an issue of fact, is inconsistent with Supreme Court precedent.