The year got off to a slow start for the pharma sector from the perspective of regulatory decisions, with the partial government shutdown not helping matters.
FDA Commissioner Scott Gottlieb clarified that applications submitted before the shutdown will be reviewed using its limited carryover user fee but it will not accept any new applications until the shutdown ends.
Last week, Bristol-Myers Squibb Co BMY 0.99% decided to withdraw its sBLA for its lung cancer combo drug as certain data required by the FDA is less likely to be available within the review cycle of the current application.
PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.
Here’re the key PDUFA dates scheduled for February.
Evolus Looks To Smile With Anti-Frown Drug
- Company: Evolus Inc EOLS 12.11%
- Type of Application: BLA
- Candidate: DWP-450
- Indication Glabellar lines, also known as frown lines
- Date: Feb. 2
The original BLA was issued a complete response letter last May, citing issues with chemistry, manufacturing and controls processes. The FDA accepted a resubmission in late August. At that time, the company said it expects the approval to come through and plans a commercial launch in the U.S. in Spring 2019.
DWP-450 is talked up as a potential rival to Allergan plc AGN 0.06%‘s Botox.
Motif’s Antibiotic
- Company: MOTIF BIO PLC/S ADR MTFB 9.22%
- Type of Application: NDA
- Candidate: Iclaprim
- Indication acute bacterial skin and skin structure infections (ABSSSI)
- Date: Feb. 13
Motif announced FDA acceptance of the NDA for Iclaprim, a gram-positive investigational antibiotic last August. The application, which has been accorded priority review designation, was filed based on data from two Phase 3 trials, namely REVIVE-1 and REVIVE-2.
Bausch Health Has Twin PDUFA Dates
- Company: Bausch Health Companies Inc BHC 0.29%
- Type of Application: NDA (both)
- Candidate: Duobrii (Plaque psoriasis) as well as Loteprednol gel 0.38 percent
- Date: Feb. 15/Feb. 25
Duobrii, chemically halobetasol propionate and tazarotene, a corticosteroid and retinoid combination, is being studied for treating plaque psoriasis. The FDA handed down a complete response letter for the lotion in June, with the agency raising questions about pharmacokinetic data. Following a resubmission done in August, the FDA set a new PDUFA date of Feb. 15.
Meanwhile, Bausch’s subsidiary Baush + Lomb had submitted the NDA for its sub-micron loteprednol etabonate ophthalmic gel in July. It’s being studied for the treatment of post-operative inflammation and pain following ocular surgery.
Will Merck’s Wonder Cancer Drug Garner Yet Another Approval?
- Company: Merck & Co., Inc. MRK 2.58%
- Type of Application: sBLA
- Candidate: Keytruda
- Indication as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma
- Date: Feb. 16
The sBLA, which was accepted by the agency in June, is based on a significant benefit in recurrence-free survival demonstrated in the pivotal Phase 3 EORTC1325/ KEYNOTE-054 trial.
Incyte/Novartis Seek Approval For Jakafi In GVHD
- Company: Incyte Corporation INCY 2.88%/ Novartis AG NVS 0.16%
- Type of Application: sNDA
- Candidate: Ruxolitinib
- Indication acute graft-versus-host disease, or GVHD, in patients who have had an inadequate response to corticosteroids.
- Date: Feb. 24
The sNDA was accepted with a priority review designation and was supported by data from the REACH1 study. GVHD is a condition that occur after an allogeneic transplant. In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body.
Ruxolitinib was initially approved for the treatment of people with polycythemia vera and later for intermediate or high-risk myelofibrosis. It’s marketed in the U.S. by Incyte and by Novartis outside of the U.S. under the brand name Jakavi.
Novo Nordisk Awaits FDA Nod For Blood Disorder Drug
- Company: Novo Nordisk A/S NVO 3.38%
- Type of Application: BLA
- Candidate: N8-GP
- Indication: Hemophilia A
- Date: Feb. 26 (estimated)
N8-GP is an extended half-life factor VIII for treatment of people with hemophilia A, a blood disorder. Novo Nordisk submitted the BLA last February. Assuming the application was accepted within the customary 60-day period, and providing for 10 months for a standard review, the PDUFA date is expected to fall in February.
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