FDA Approved Drugs: March & April, 2022

Vivjoa (Oteseconazole)

Vivjoa, the first FDA-approved product for Mycovia, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations to become the first FDA-approved therapy for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Pharmaceuticals Co., Ltd., to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan, and Gedeon Richter Plc., a Hungary-based pharmaceutical company, to commercialize and manufacture oteseconazole in Europe, Russia, the Commonwealth of Independent States, Latin America and Australia. Mycovia also recognizes a tremendous potential for its oral fungal inhibitors and a growing need to treat a range of multi-drug resistant fungal pathogens.

Camzyos (Mavacamten)

Camzyosis the FIRST AND ONLY cardiac myosin inhibitor approved by the FDA indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. Camzyos is an allosteric and reversible inhibitor selective for cardiac myosin. Camzyos modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. Camzyos shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In HCM patients, myosin inhibition with Camzyos reduces dynamic LVOT obstruction and improves cardiac filling pressures.

Ztalmy (Ganaxolone)

Ztalmy, a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor, is taken three times daily. Ztalmy is the FIRST ANDONLY FDA-approved treatment indicated specifically for seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients two years of age and older.

PLUVICTO™ (Lutetium Lu 177 vipivotide tetraxetan)

Pluvictois a PSMA targeted radioligand therapy that delivers DNA-breaking radiation directly to the PSMA positive bone, nodal and visceral metastases. It is the FIRST AND ONLY PSMA-targeted radioligand therapy for men with PSMA+ mCRPC who have been treated with androgen receptor pathway inhibitors and a taxane-based chemotherapy.

FDA Approved Drugs: February 2020

FDA Approved Drugs: February 2020

Pizensy (lactitol): Braintree Labs

Pizensy (lactitol) is an osmotic laxative therapy indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Pizensy will be supplied as a powder for oral solution as 280 grams and 560 grams of lactitol in multi-dose bottles, as well as 28 unit-dose packets each containing 10 grams of lactitol. The product can be mixed with the patient’s fluid of choice and is taken once daily, preferably with meals. Pizensy is expected to be available in the United States in H2 2020. Pizensy is a New Chemical Entity and is expected to have patent protection until 2037.

Nexletol & Nexlizet (bempedoic acid and ezetimibe): Esperion Therapeutics

Nexletol is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver. Nexletol will be commercially available in the United States by March 30, 2020. Nexlizet is a combination of an adenosine triphosphate-citrate lyase (ACL) inhibitor, bempedoic acid, and ezetimibe, a cholesterol absorption inhibitor. The FDA approval of Nexletol and Nexlizet provides an important option for patients living with elevated LDL-C and ASCVD or increased risk for cardiovascular disease. High LDL, or bad cholesterol, is one of the top risks for heart attacks and other problems.

Barhemsys (amisulpride):Acacia Pharma

Barhemsys is the first and only antiemetic approved therapy for the ‘rescue treatment’ (patients who are uncontrolled following prophylactic treatment with standard-of care-antiemetics) and prophylaxis of Postoperative Nausea and Vomiting (PONV) in patients who have failed prior prophylaxis using current standard of care. It is an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride (2.5 mg/mL).

Nurtec ODT (rimegepant):Biohaven Pharmaceuticals

Nurtec ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT).The approval of Nurtec ODT was based on efficacy data from a randomized, double-blind, placebo-controlled Phase III trial that compared Nurtec ODT with placebo in 1466 adult patients for the acute treatment of migraine with and without aura. Nurtec ODT will be supplied as 75mg orally disintegrating tablets in a blister pack of 8 and is expected to be available in early March 2020.