RECENT FDA APPROVAL:
AYVAKIT ™ (avapritinib)
The FDA approved Ayvakit ™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) with a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. Ayvakit ™ is a kinase inhibitor that blocks an enzyme called a kinase and prevents the cancer cells from growing. Itis supplied as 100 mg, 200 mg, and 300 mg tablets. www.ayvakit.com
BARHEMSYS® (amisulpride)
Barhemsys® (amisulpride injection) is approved for the prevention and treatment of postoperative nausea and vomiting (PONV) in adult patients. Barhemsys® is also approved for prevention of PONV, either alone or in combination with an antiemetic of a different class. It is the first and only antiemetic to be approved for rescue treatment of PONV in patients who have failed prior prophylaxis using current standard of care. Barhemsys® is an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209510s000lbl.pdf
FLUAD® QUADRIVALENT (influenza vaccine, adjuvanted)
The FDA approved Fluad® Quadrivalent (influenza vaccine, adjuvanted) for active immunization in patients 65 years of age and older against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. Fluad® Quadrivalent (aQIV) utilizes the same MF59® adjuvant technology as Fluad® (aTIV), designed to create a strong, broad and durable immune response. Fluad® Quadrivalent will be supplied in 0.5mL single-dose prefilled syringes. https://www.fda.gov/vaccines-blood-biologics/vaccines/fluad
ISTURISA® (osilodrostat)
Isturisa® (osilodrostat) is FDA approved for the treatment of adults with Cushing’s disease who are not eligible for pituitary gland surgery or for those who had surgery but still have the disease. Cushing’s disease is a rare disease where the adrenal glands produces excess amounts of the hormone cortisol. Isturisa® is the first FDA-approved drug that directly target cortisol overproduction by inhibiting 11-beta-hydroxylase enzyme and preventing cortisol synthesis. It is taken orally twice a day and the dosage may be adjusted based upon the patient’s response. It is supplied as 1 mg, 5 mg, and 10 mg tablets. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-cushings-disease
NEXLIZET™ (bempedoic acid and ezetimibe)
The FDA approved Nexlizet™ (bempedoic acid and ezetimibe) for lowering LDL-Cholesterol (LDL-C). The drug is an oral, once-daily, non-statin indicated with diet and maximally tolerated statins for adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who need additional help lowering LDL-C. Nexlizet™ is an adenosine triphosphate-citrate lyase (ACL) inhibitor and a cholesterol absorption inhibitor. It is supplied in 180 mg bempedoic acid/10 mg ezetimibe tablets. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf
NURTEC™ ODT (rimegepant)
Nurtec™ ODT (rimegepant) the first calcitonin gene-related peptide (CGRP) receptor antagonist received FDA approval and is available in a fast-acting orally disintegrating tablet for the acute treatment of migraine in adults. Nurtec™ ODT will be supplied in 75 mg disintegrating tablets. https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-nurtec-odt
NUMBRINO™ (cocaine hydrochloride) nasal solution
The FDA approved Numbrino™ (cocaine hydrochloride) nasal solution for local anesthesia of the mucous membranes for diagnostic procedures and surgeries of the nasal cavities in adults. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209575s000lbl.pdf
PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp]
Palforzia™, is the first FDA approved treatment for patients with peanut allergy. It is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Treatment with this oral immunotherapy may be initiated in individuals age 4 years to 17 years with a confirmed diagnosis of peanut allergy, and may be continued in individuals 4 years of age and older. Those who take this therapy must continue to avoid peanuts in their diets. Palforzia™ is supplied in 0.5 mg 1 mg, 10 mg, 20 mg and 100 mg capsules or 300 mg sachets. https://www.fda.gov/vaccines-blood-biologics/allergenics/palforzia
Sarclisa® (isatuximab-irfc – Sanofi)
Sarclisa® (isatuximab-irfc – Sanofi) was given early approval from the U.S. Food and Drug Administration (FDA) on March 2, 2020. A CD38-directed cytolytic antibody, it is to be used along with Pomalyst® (pomalidomide) and dexamethasone (pom-dex) for the treatment of adults who have multiple myeloma that already has been treated two or more times with Revlimid® (lenalidomide) and a proteasome inhibitor, such as bortezomib. It will be administered by intravenous (IV) infusions of 10mg/kg once every week for four weeks and then once every other week. Launch of Sarclisa® is expected at a wholesale acquisition cost (WAC) of $650/100mg and $3,250/500mg. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf
TAZVERIK™ (tazemetostat)
The FDA approved Tazverik™ (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults. Tazverik™ is the first and only FDA-approved EZH2 inhibitor which may prevent cancer cells from growing. Tazverik™ is supplied as 200 mg tablets. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tazverik
Tepezza™ (teprotumumab-trbw – Horizon Therapeutics)
Tepezza™ (teprotumumab-trbw) is for the treatment of Thyroid Eye Disease (TED). Tepezza™ is the first and only FDA-approved medicine for the treatment of TED, a rare and progressive autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation and facial disfigurement. Tepezza™ is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks. Horizon plans a launch the product at a wholesale acquisition cost (WAC) of $14,900 per vial. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761143s000lbl.pdf
TRIJARDY™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets)
The FDA approved Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. Trijardy™ XR provides three type 2 diabetes medications into one tablet, comprising of Jardiance® (empagliflozin), Tradjenta® (linagliptin) and metformin hydrochloride extended release. The triple-combination tablet will be supplied in four strengths: 5mg empagliflozin/2.5mg linagliptin/1000mg metformin HCl extended-release; 10mg/5mg/1000mg; 12.5mg/2.5mg/1000mg; and 25mg/5mg/1000mg tablets. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212614s000lbl.pdf
VYEPTI™ (eptinezumab-jjmr)
The FDA approved Vyepti™ (eptinezumab-jjmr) for the preventive treatment of migraine in adults.
Vyepti™ is a calcitonin gene-related peptide (CGRP) inhibitor that is administered as an intravenous (IV) infusion once every 3 months. It will be supplied in 100mg/mL single-dose vial. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761119s000lbl.pdf