New Drugs: FDA Follows Through on

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

TheFDArecentlyapprovedthefirstgenericforDaraprim® (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.ThispriceincreasewashighlycriticizedasDaraprim® 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.

Biologicals: Palforzia™ (peanut (Arachis hypogaea) allergen 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 priorityreviewas anorphandrugasthefirstagenttotreatthyroideyedisease.

Oncology: Nubeqa™ (darolutamide) is an oral androgen 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 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 generelated 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)injectionhasbeenapprovedfor the treatment of moderate-to-severe pain as monotherapy or with other NSAIDs.

New Dosage Forms: Significant new dosage forms 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 biosimilartoHerceptin®; Monoferric®(ferricderisomaltose, 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. §