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FDA Follows Through on Commitment to Increase Competition and Lower Drug Costs By guest authors Wali Abdul, PharmD/MBA Candidate and Brittany Petty, PharmD Candidate
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he FDA recently approved the first generic for Daraprim® (pyrimethamine), the antiparasitic drug that made headlines in 2015 when Martin Sckreli, CEO exponentially increased its price by 5,000% from $13.50 to $750.00 per tablet. This price increase was highly criticized as Daraprim® is a lifesaving medication and the only one of its kind to help treat certain populations. The FDA followed through on its commitment to increase competition with generic availability.
approved as adjunct therapy for heterozygous familial hypercholesterolemia or established atherosclerotic disease who require additional lowering of LDL. Pizensy™ (lactitol) is an osmotic laxative used to treat chronic idiopathic constipation.
Acute: Nurtec™ (rimegepant) is the first calcitonin gene-
powder-dnfp) oral immunotherapy is the first treatment for mitigation of allergic reactions including anaphylaxis that may occur with accidental exposure to peanuts. Tepezza™ (teprotumumab-trbw) was approved through priority review as an orphan drug as the first agent to treat thyroid eye disease.
related peptide receptor antagonist available in an orally disintegrating tablet for migraines. Barhemsys® (amisulpride) injection is a dopamine-2 antagonist which is the first antiemetic approved as rescue treatment of PONV in patients who have failed prophylaxis with the current standard of care. Anjeso™ (meloxicam) injection has been approved for the treatment of moderate-to-severe pain as monotherapy or with other NSAIDs.
Oncology: Nubeqa™ (darolutamide) is an oral androgen
New Dosage Forms: Significant new dosage forms
Biologicals: Palforzia™ (peanut (Arachis hypogaea) allergen
receptor inhibitor for non-metastatic castration-resistant prostate cancer. Ayvakit™ (avapritinib) was granted breakthrough therapy designation through fast-track review as a kinase inhibitor to treat unresectable or metastatic gastrointestinal stromal tumors. Tazverik™ (tazemetostat) received accelerated approval as an orphan drug through priority review to treat metastatic or locally advanced epithelioid sarcoma. Sarclisa® (isatuximab-irfc) is an antiCD38 monoclonal antibody to treat adults with multiple myeloma who have received >2 therapies including lenalidomide and a proteasome inhibitor.
Chronic Care: Caplyta® (lumateperone) received fast-track
approval as an atypical antipsychotic for schizophrenia. Dayvigo™ (Lemborexant) is an orexin receptor antagonist for insomnia. Isturisa® (osilodrostat) is an orphan drug and first agent approved to address the overproduction of cortisol as a cortisol synthesis inhibitor for non-surgical treatment of Cushing’s disease. Vyepti™ (eptinezumab-jjmr) for IV use is a calcitonin gene-related peptide antagonist indicated for prevention of migraines. Nexletol™ (bempedoic acid) is an adenosine triphosphate-citrate lyase inhibitor
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approved this quarter include: Avsola™ (infliximab-axxq, IV) a biosimilar to Remicade®; Conjupri® (levamlodipine, tablets) for hypertension; Bynfezia Pen™ (octreotide, SQ) for acromegaly, carcinoid tumors, or vasoactive intestinal peptide tumors; Hadlima™ (adalimumab-bwwd, SQ) a biosimilar to Humira®; Kanjinti™ (trastuzumab-anns, IV) a biosimilar to Herceptin®; Monoferric® (ferric derisomaltose, IV) for anemia; Ruxience™ (rituximab-pvvr, IV) a biosimilar to Rituxan™; Twirla® (levonorgestrel and ethinyl estradiol, transdermal patch) for contraception in women with BMI <30 kg/m2; Trijardy™ XR (empagliflozin/linagliptin/metformin) for type 2 diabetes; and Valtoco® (diazepam, nasal spray) for acute seizures. §
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