New Drugs: Oncology and Chronic Care Drugs Still Priority During Pandemic

Oncology and Chronic Care Drugs Still Priority During Pandemic

Despite fear the FDA would be inundated with requests related to COVID-19 slowing the approval of other lifesaving medications, the agency has managed to approve 29 new drugs and biologicals and authorize 13 new dosage forms from June through September.

Acute Care: Byfavo™ (remimazolam) is a rapid-acting injectable benzodiazepine for induction and maintenance of procedural sedation. Sevenfact® (factor VIIA, recombinantjncw) is a coagulation factor used to control bleeding in patients with hemophilia A or B with inhibitors. Xeglyze™ (abametapir) is a lotion for the treatment of headlice in patients >6 months. Olinvyk™ (oliceridine) received fast track status for acute pain relief during procedures.

Chronic Care: Bafiertam™ (monomethyl fumarate), the active metabolite of dimethyl fumarate, has been approved for relapsing forms of multiple sclerosis. Dojolvi™ (triheptanoin) is a liquid medium-chain triglyceride used as a source of calories and fatty acids for patients with long-chain fatty acid oxidation disorders. Hulio™ (adalimumab-fkjp) has become the sixth approved biosimilar to the anti-TNF agent, Humira®. Lyumjev™ (insulin lispro-aabc), is a new rapid-acting insulin analog for diabetes available in two concentrations—100 and 200 units/mL. Nexlizet™ (bempedoic acid/ezetimibe) is approved as adjunct to diet and statin therapy for the treatment of familial hypercholesterolemia. Palforzia® (peanut, arachis hypogaea allergen powder-dnfp) is an oral powder immunotherapy approved for mitigation of peanut allergic reaction. QWO™ (collagen clostridium histoyticum-aaes) is an injectable treatment approved for moderate to severe cellulite in women. Rukobia (fostemsavir) is a novel HIV-1 gp 120-directed attachment inhibitor indicated in combination with other antiretrovirals for multidrug-resistant HIV-1 infection. Semglee™ (insulin glargine) is a long-acting insulin to be marketed by Mylan as an affordable alternative to Lantus®. Both Uplizna™ (inebilizumab-cdon), a novel B-cell depleting monoclonal antibody, and Enspryng™ (satralizumab-mwge), an IL-6 receptor antagonist, have been approved to treat neuromyelitis optica spectrum disorder in adults who are anti-AQP4 antibody positive. Sogroya (somapacitan) is the first subcutaneous human growth hormone dosed weekly. Winlevi® (clascoterone) is a novel topical acne treatment that inhibits the androgen receptor. Viltepso™ (viltolarsen) received accelerated approval for the treatment of Duchenne muscular dystrophy. Evrysdi™ (risdiplam) was approved for the treatment of spinal muscular atrophy. Lampit® (nifurtimox), an antiprotozoal medication, received accelerated approval for the treatment for Chagas disease in patients <18 years old. Oncology: Darzalex Faspro™ (daratumumab/hyaluronidasefihj) subcutaneously administered treatment for multiple myeloma. Inqovi® (decitabine/cedazuridine) as an oral combination was granted priority review for myelodysplastic syndromes and chronic myelomonocytic leukemia. Nyvepria (pegfilgrastim-apgf) is a colony stimulating factor and the 4th biosimilar for Neulasta®. Phesgo™ (pertuzumab/ trastuzumab/hyaluronidase-zzxf) is a monoclonal antibody administered subcutaneously in combination with other drugs for HER2-positive breast cancer. Zepzelca™ (lurbinectedin) is an alkylating drug that was granted accelerated approval for metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. Monjuvi™ (tafasitamabcxix) was approved to treat relapsed or refractory diffuse large B-cell lymphoma. Blenrep (belantamab mafodoti-blmf), the world’s first anti-B-cell maturation agent monoclonal antibody, received accelerated approval to treat multiple myeloma. Gavreto™ (pralsetinib) received accelerated approval for certain types of non-small cell lung cancer. Detectnet™ (copper CU 64 dotatate injection), a diagnostic agent used with PET, is approved for the localization of somatostatin receptor positive neuroendocrine tumors in adults.

New Dosage Forms: Several new dosage forms were approved including: Fintepla® (fenfluramine, oral solution) for seizures associated with Dravet syndrome; Gimoti™ (metoclopramide, nasal spray) for patients with diabetic gastroparesis; Impeklo™ (clobetasol propionate, lotion) for corticosteroid-responsive dermatosis; Kynmobi™ (apomorphine, sublingual film) for intermittent treatment of “off” episodes of Parkinson’s disease; Mycapssa® (octreotide, oral capsule) for long-term maintenance treatment of acromegaly; Oriahnn® (elagolix/estradiol norethindrone, capsules) for fibroid-associated heavy menstrual bleeding in premenopausal women; Phexxi™ (lactic acid/citric acid/potassium bitartrate, vaginal gel) for on-demand prevention of pregnancy; Tivicay PD® (dolutegravir, oral tablet for suspension) for HIV-1 infection in patients > 4 weeks old and weighing at least 3 kilograms; Upneeq™ (oxymetazoline, ophthalmic solution) for blepharoptosis (droopy eyelid); Zilxi™ (minocycline, topical foam) for adult rosacea; Breztri Aerosphere™ (budesonide, glycopyrrolate, and formoterol fumarate, metered dose inhaler) as COPD maintenance treatment; Wynzora® (calcipotriene/ betamethasone dipropionate, cream) for plaque psoriasis; and Xywav™ (calcium, magnesium, potassium, and sodium oxybates), containing 92% less sodium per dose than comparable sodium oxybate (Xyrem™), both from Jazz pharmaceuticals, for narcolepsy. §