The U.S. Food and Drug Administration approved Novartis’ Leqvio (inclisiran), the first small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year, after an initial dose and one at three months.
In a long-running court battle over PCSK9 antibodies, Amgen lost the company’s bid to uphold patent claims for the cholesterol drug Repatha against rival drug Praluent, developed by Sanofi and Regeneron.
Biggest Novel Drug Approvals in 2020"Bad" LDL Cholesterol, Acute Migraine, Antibodies, Coronavirus Disease (COVID-19) Pandemic, Coronavirus Disease 2019 (COVID-19), EvaluatePharma, FDA, Future Blockbusters, New Drug Approvals, Peanut Allergies, Relapsing Multiple Sclerosis (RMS), Spinal Muscular Atrophy (SMA), Therapeutics, Thyroid Eye Disease (TED), Triple Negative Breast Cancer (TNBC)
BioSpace reviewed the top 10 novel drug approvals of 2020, loosely based on projected earnings in the upcoming years.
Results of Viking Therapeutics’ metabolic disease program exceed all other oral therapies in development in terms of reducing liver fat for nonalcoholic steatohepatitis (NASH) patients, according to Greg Zante, the company’s SVP of finance.
Swiss drugmaker Novartis grabbed a key European panel’s recommendation for Leqvio, clearing the way for the prospective cholesterol drug’s approval in the next couple of months.
The U.S. Food and Drug Administration approved Ann Arbor, Michigan-based Esperion’s Nexlizet (bempedoic acid and ezetimibe) for lowering LDL cholesterol.
The U.S. Food and Drug Administration approved Michigan-based Esperion’s oral, once-daily, non-statin LDL-cholesterol lowering medicine Nexletol (bempedoic acid).
One week after announcing positive data from ORION-10, the second of three 19-month Phase III trials for inclisiran for lowering cholesterol, The Medicines Co. was acquired by Novartis.
The Medicines Company’s inclisiran hit the primary and secondary endpoints in a Phase III trial to decrease LDL cholesterol through twice-a-year dosing.
Regeneron Pharmaceuticals announced positive results from the company’s pivotal Phase III clinical trial of evinacumab in homozygous familial hypercholesterolemia (HoFH).