Traditional Drug Pipeline Update: April 2023

This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate article for pipeline information on specialty drugs.

New Drug Information

• Rezzayo™ (rezafungin): The U.S. Food and Drug Administration (FDA) has approved Cidara and Melinta’s Rezzayo for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Rezzayo is an echinocandin antifungal that is supplied as a solid (cake or powder) in a single-dose vial containing 200mg of rezafungin. Treatment is administered once weekly by intravenous infusion after reconstitution. The approval was based on the Phase 3 ReSTORE study which demonstrated treatment with Rezzayo was found to be noninferior to caspofunginfor the primary endpoint of all-cause mortality at day 30, using a 20% noninferiority margin. All-cause mortality at day 30 was reported to be 23.7% for the Rezzayo group and 21.3% for the caspofungin group.¹ Rezzayo launch and price are pending.
• Naloxone Hydrochloride Nasal Spray™ (naloxone): Amphastar’s Naloxone Hydrochloride Nasal Spray 4mg was approved by the FDA for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression for adult and pediatric patients. Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.²Naloxone Hydrochloride Nasal Spray is supplied as a carton containing 2 unit-dose devices; each device delivers a single spray containing 4mg of naloxone hydrochloride (equivalent to 3.6mg of naloxone). The device is ready to use and does not require priming or testing prior to administration. According to IQVIA, the U.S. sales of previously approved naloxone hydrochloride nasal spray 4mg in 2022 was approximately $250 million for the 12 months ended December 31, 2022.³ Naloxone Hydrochloride Nasal Spray 4mg launch and price are pending.
• RizaFilm^® (rizatriptan) oral film: The FDA has approved RizaFilm for the treatment of acute migraine. RizaFilm was approved via the 505(b)(2) pathway using Merck & Co.’s Maxalt^® (rizatriptan benzoate) as its reference product. The global migraine drugs market was valued at nearly $3 billion in 2021 and is expected to reach nearly $11 billion by 2030, representing a compound annual growth rate of 15.6%.⁴ Launch and price are anticipated shortly.

Generic Drug Information

• Noxafil^® Suspension (posaconazole susp 40 mg/mL): Multiple manufacturers launched their generic version of Merck Sharp & Dohme’s Noxafil suspension for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Noxafil suspension is also indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole. Noxafil suspension generated $19 million in U.S. annual sales in 2022.
• Uceris^® Rectal Foam (budesonide rectal foam, 2mg/act): Padagis has launched their version of Bausch Health’s Uceris rectal foam. Uceris rectal form is a glucocorticosteroid indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. Uceris Rectal Foam generated $14 million in U.S. annual sales in 2022.

+Specialty medication

All New Indications for Specialty and Non-Specialty in 2023:

Brand Name	Generic Name	Manufacture	Indication	Approval Date
Narcan® (nasal spray)	naloxone hydrochloride	Adapt Pharma/ Emergent BioSolutions/ Opiant	Opioid overdose	03/29/2023
Evkeeza® IV	evinacumab-dgnb	Regeneron	Certain forms of homozygous familial hypercholesterolemia (HoFH)	03/21/2023
Livmarli®	maralixibat chloride	Takeda/ Mirum Pharmaceuticals/ Shire	Alagille syndrome	03/13/2023
Revatio® (oral suspension)	sildenafil citrate	Pfizer/ Viatris	Pulmonary arterial hypertension	03/03/2023
Kevzara®	sarilumab	Sanofi/ Regeneron	Polymyalgia rheumatica	02/28/2023
Cibinqo® (tablet)	abrocitinib	Pfizer	Atopic dermatitis	02/09/2023
Eylea®	aflibercept	Regeneron	Retinopathy of prematurity (ROP)	02/08/2023
Trodelvy®	sacituzumab govitecan-hziy	Gilead/ Immunomedics	Certain forms of hormone receptor positive breast cancer	02/03/2023
Takhzyro® SC	lanadelumab	Takeda/ Dyax/ Shire	Prophylaxis against angioedema attacks in hereditary angioedema	02/03/2023
Tezspire®	tezepelumab-ekko	AstraZeneca/ Amgen/ MedImmune	Severe asthma	02/01/2023
Revatio® (tablet)	sildenafil citrate	Pfizer/ Viatris	Certain forms of pulmonary arterial hypertension	01/31/2023
Keytruda®	pembrolizumab	Merck & Co	Certain forms of Non-small cell lung cancer (NSCLC)	01/26/2023
Brukinsa®	zanubrutinib	BeiGene	Chronic lymphocytic leukemia	01/19/2023
Tukysa®	tucatinib	Seattle Genetics/ Seagen	Certain forms of colorectal cancer	01/19/2023

References

1. https://www.businesswire.com/news/home/20230322005767/en/Cidara-Therapeutics-and-Melinta-Therapeutics-Announce-FDA-Approval-of-REZZAYO%E2%84%A2-rezafungin-for-injection-for-the-Treatment-of-Candidemia-and-Invasive-Candidiasis
2. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray
3. https://ir.amphastar.com/websites/amphastar/English/2110/news-detail.html?airportNewsID=fd568d0c-36f7-43b9-a888-87c8afa3e096
4. https://www.globenewswire.com/news-release/2023/04/17/2647913/0/en/IntelGenx-Announces-FDA-Approval-of-RIZAFILM-for-the-Treatment-of-Acute-Migraine.html