Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates
The FDA worked overtime through the coronavirus (COVID-19) crisis, framing new guidelines for approving SARS-CoV-2 diagnostic tests, reviewing tests and treatments.
Even amid its response to the emergency, the agency went about its business as usual. Bristol-Myers Squibb Co's (NYSE: BMY) combo therapy was approved for advanced liver cancer.
Two new molecular entities - Novartis AG's (NYSE: NVS) Isturisa oral tablets for adults with Cushing's disease and Sanofi SA's (NASDAQ: SNY) Sarclisa, in combination with omalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma – were approved during the month.
Here are the key PDUFA dates scheduled for April.
Related Link: 8 Biotechs With Coronavirus Vaccines In Development
Bristol-Myers, Acceleron Squibb Seek Label Expansion For Anemia Drug
Company: Acceleron Pharma Inc (NASDAQ: XLRN) and Bristol-Myers Squibb Co (NYSE: BMY)
Type of Application: sBLA
Candidate: Luspatercept
Indication: myelodysplastic syndromes
Date: April 4
The sBLA for Luspatercept, sponsored by Acceleron and Celgene, which has since then been acquired by Bristol-Myers Squibb, was accepted for review by the FDA in June 2019, with the agency setting a PDUFA action date of April 4.
In early December, the companies said the FDA cancelled a review of the BLA by the Oncologic Drugs Advisory Committee, which was scheduled for Dec. 18.
Luspatercept, an erythroid maturation agent, has already been approved for treating anemia in patients with beta thalassemia, who require regular red blood cell transfusions.
Go Or No-Go For Urogen's Kidney Cancer Drug?
Company: Urogen Pharma Ltd (NASDAQ: URGN)
Type of Application: NDA
Candidate: UGN-101 (mitomycin gel)
Indication: low-grade upper tract urothelial cancer, or LG UTUC
Date: April 18
The FDA accepted the NDA for review Dec. 19 and granted priority review status. UGN-101 already has Orphan Drug, Fast Track and Breakthrough Therapy designations.
"If approved, UGN-101 would be the first non-surgical treatment option for LG UTUC," the company had said.
FDA To Rule On Sanofi's Vaccine For Bacterial Form Of Meningitis
Company: Sanofi SA (NASDAQ: SNY)
Type of Application: BLA
Candidate: MenQuadfi
Indication: vaccine for meningococcal meningitis
Date: April 25
Neurocrine's Parkinson's Drug Under FDA Scanner
Company: Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
Type of Application: NDA
Candidate: Opicapone
Indication: Parkinson's disease
Date: April 26
Opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor is being evaluated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes. The FDA accepted the regulatory application in July.
Can United Therapeutics' Drug-Device Combo For Hypertension Scale Regulatory Hurdle?
Company: United Therapeutics Corporation (NASDAQ: UTHR)
Type of Application: NDA
Candidate: Trevyent
Indication: pulmonary arterial hypertension
Date: April 27
Trevyent is a drug-device combination product that combines two-day, single use, disposable PatchPump technology with treprostinil, for the subcutaneous treatment of PAH.
The company, however, indicated in its Feb. earnings release it received a mid-cycle information request from the FDA, noting several deficiencies in the NDA. Although the company has given a written response, based on interactions with the FDA, it said the PDUFA date could be extended beyond April.
Pfizer's Combo Therapy To Treat Colorectal Cancer Awaits Clearance
Company: Pfizer Inc. (NYSE: PFE)
Type of Application: sNDA
Candidate: Braftovi in combination with Bristol-Myers' Erbitux
Indication: metastatic colorectal cancer
Date: April (date not specified)
The Braftovi-Erbitux combo is being evaluated as a treatment option for patients with advanced BRAFV600E-mutant metastatic colorectal cancer, following one or two lines of therapy. The FDA accepted the sNDA for review on Dec. 18.
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