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 BMY 2.48% combo therapy was approved for advanced liver cancer.
Two new molecular entities – Novartis AG’s NVS 0.68% Isturisa oral tablets for adults with Cushing’s disease and Sanofi SA’s SNY 2.17% 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.
Acceleron, Bristol-Myers Squibb Seek Label Expansion For Anemia Drug

• Company: Acceleron Pharma Inc XLRN 5.09% and Bristol-Myers Squibb Co BMY 2.48%
• 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 URGN 1.76%
• 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 SNY 2.17%
• 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. NBIX 5.5%
• 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 UTHR 2.31%
• 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. 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.
https://www.benzinga.com/general/biotech/20/03/15665215/attention-biotech-investors-mark-your-calendar-for-these-april-pdufa-dates