While the healthcare industry looks for ways to combat COVID-19, the beat goes on for drug manufacturers to continue developing and seeking marketing approval for medicines to treat many diseases and conditions. Here is a look at some of the most notable U.S. new drug approvals from Jan. 1 through April 17, 2020.
Brand (chemical): Tukysa (tucatinib)
U.S. approval date: April 17
Company: Seattle Genetics
Description: Approved in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting; first HER-2 tyrosine kinase inhibitor in combination to improve overall and progression-free survival in patients with metastatic HER2-positive breast cancer with or without brain metastases.
Brand (chemical): Koselugo (selumetinib)
U.S. approval date: April 10
Description: Approved for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN); first regulatory approval of a medicine for the treatment of NF1 PN.
Brand (chemical): Zeposia (ozanimod)
U.S. approval date: March 25
Company: Bristol-Myers Squibb
Description: Approved for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting (RMS) disease and active secondary progressive disease; only approved sphingosine-1-phosphate receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients.
Brand (chemical): Isturisa (osilodrostat)
U.S. approval date: March 6
Company: Recordati and Novartis
Description: Approved for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative; first FDA-approved inhibitor of 11-beta-hyrdoxylase that has demonstrated normalization of cortisol levels in a significant portion of adult patients with a manageable safety profile.
Brand (chemical): Sarclisa (isatuximab-irfc)
U.S. approval date: March 2
Description: Approved in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
Brand (chemical): Nurtec ODT (rimegepant)
U.S. approval date: Feb. 27
Company: Biohaven Pharmaceuticals
Description: Approved for the acute treatment of migraine in adults; first calcitonin gene-related peptide receptor antagonist available in a fast-acting orally disintegrating tablet (ODT).
Brand (chemical): Barhemsys (amisulpride injection)
U.S. approval date: Feb. 26
Company: Acacia Pharma Group
Description: Approved as the first antiemetic for the rescue treatment of postoperative nausea and vomiting (PONV) in patients who have failed prior prophylaxis using current standard of care; also approved for the prevention of PONV, either alone or in combination with an antiemetic of a different class.
Brand (chemical): Vyepti (eptinezumab-jjmr)
U.S. approval date: Feb. 21
Company: H. Lundbeck
Description: Approved for the preventive treatment of migraine in adults; first intravenous preventive treatment for migraine; Vyepti clinical program is the first to demonstrate the early benefit of preventing migraine over time while also delivering on the need for earlier onset of efficacy.
Brand (chemical): Nexletol (bempedoic acid)
U.S. approval date: Feb. 21
Company: Esperion Therapeutics
Description: Approved as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C; first oral, once-daily, non-statin LDL-cholesterol lowering medicine approved in the U.S. in nearly 20 years for indicated patients; first-in-class ATP Citrate Lyase inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver.
Brand (chemical): Pizensy (lactitol)
U.S. approval date: Feb. 12
Company: Sebela Pharmaceuticals
Description: Approved for oral solution for the once-daily treatment of chronic idiopathic constipation in adults; first FDA-approved product which the patient can self-titrate based on their own results for stool consistency.
Brand (chemical): Palforzia ([Peanut (Arachis hypogaea) Allergen Powder-dnfp])
U.S. approval date: Jan. 31
Company: Aimmune Therapeutics
Description: Approved for use in patients with a confirmed diagnosis of peanut allergy; first approved treatment for patients with peanut allergy; first approved therapy for any food allergy.
Brand (chemical): Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted)
U.S. approval date: Jan. 31
Company: Seqirus, part of CSL
Description: Approved to help protect individuals 6 months of age and older against influenza A (H5N1); first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A in the event of a pandemic.
Brand (chemical): Tazverik (tazemetostat)
U.S. approval date: Jan. 23
Description: Approved for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for complete resection; first FDA-approved treatment specifically indicated for ES patients; first EZH2 inhibitor approved by the FDA.
Brand (chemical): Tepezza (teprotumumab-trbw)
U.S. approval date: Jan. 21
Company: Horizon Therapeutics
Description: Approved for the treatment of thyroid eye disease (TED); first FDA-approved medicine for the treatment of TED.
Brand (chemical): Ayvakit (avapritinib)
U.S. approval date: Jan. 9
Company: Blueprint Medicines
Description: Approved for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations; first precision therapy approved to treat a genomically defined population of patients with GIST; only FDA-approved type 1 inhibitor for GIST that works by directly binding to the active kinase conformation from which mutant KIT and PDGFRA signal.