September turned out to be a fruitful month for FDA approvals. The regulatory agency gave its nod to Ardelyx Inc ARDX's Ibsrela, a new molecular entity indicated to treat irritable bowel syndrome with constipation in adults.
With Ibsrela, NME approvals for the year totaled 27, lower than the 41 approvals given by the same time last year.
Some of the therapies that crossed the FDA hurdle included Johnson & Johnson JNJ's Janssen unit's Erleada for the expanded indication of metastatic castration-sensitive prostate cancer; Novo Nordisk A/S NVO's oral semaglutide for Type 2 diabetes; and Merck & Co., Inc. MRK's HIV drugs Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).
The following are the key PDUFA dates for the upcoming month.
Gilead Seeks Label Expansion For HIV Combo Drug
Company: Gilead Sciences, Inc. GILD
Type of Application: sNDA
Candidate: Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets)
Indication: Pre-exposure prophylaxis, or PrEP, for HIV-1 infection
Date: Oct. 4 (Estimated, assuming 6-month review period due to the priority voucher submitted with the application)
Descovy was initially approved in April 2016 to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients ages 12 and older.
Gilead is now eyeing approval for Descovy as a preventive treatment for reducing the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV.
An FDA panel that met in August voted 16-2 to recommend approval of Descovy as PrEP to reduce the risk of HIV acquisition in men having sex with men and transgender women. The panel voted 8-10 against approving it for cisgender women.
Will Clinuvel's Phototoxicity Drug See The Light?
Company: Clinuvel Pharmaceuticals Ltd CLVLY
Type of Application: NDA
Candidate: Scenesse
Indication: prevention of phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria, or EPP
Date: Oct. 6
Scenesse is a controlled release injectable implant containing afamelanotide, which is being developed as a first-line treatment for patients with EPP, a rare genetic metabolic disorder that causes phototoxicity and anaphylactoid reactions when patients expose their skin to light.
In June, the FDA communicated its decision to extend the review period by three months to provide it with more time for the review of the full NDA submission.
Pfenex Seeks Nod For Therapeutic Equivalent of Lilly's Osteoporosis Drug
Company: Pfenex Inc PFNX
Type of Application: NDA
Candidate: PF708
Indication: Osteoporosis
Date: Oct. 7
F708 is a therapeutic equivalent of Eli Lilly And Co LLY's Forteo, which was approved in 2002 to treat osteoporosis in men and menopausal women who are at high risk of having a fracture.
Forteo's global sales stood at $1.6 billion in 2018.
Roche's Blood Vessel Inflammation Drug Awaits FDA Nod
Company: Roche Holdings AG Basel ADR RHHBY
Type of Application: sBLA
Candidate: MabThera/Rituxan in combination with glucocorticoids
Indication: treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children two years of age and older
Date: Oct. 11. This is estimated, assuming the filing of the application two months prior to the sBLA acceptance date of June 12.
Granulomatosis with polyangiitis and microscopic polyangiitis are rare, potentially life-threatening diseases affecting small- and medium-sized blood vessels.
J&J's Seeks Another Label Expansion For Anticoagulant Drug Xarelto
Company: J&J's Janssen unit
Type of Application: sNDA
Candidate: Xarelto
Indication: prevention of venous thromboembolism in medically ill patients
Date: Oct. 13 (estimated)
Xarelto, an anticoagulant, was initially approved for prophylactic treatment of deep vein thrombosis that may lead to pulmonary embolism in people undergoing knee or hip replacement surgery. Since then, J&J had secured several label expansions for the drug.
FDA To Rule On Second Indication For Flexion's Osteoarthritis Drug
Company: Flexion Therapeutics Inc FLXN
Type of Application: sNDA
Candidate: Zilretta
Indication: repeat administration for osteoarthritis of the knee
Date: Oct. 14
Zilretta was initially approved in Oct. 2017 as an extended-release, intra-articular injection for osteoarthritis knee pain. In the recent second quarter, Zilretta sales rose 60% quarter-over-quarter to $17 million.
Will FDA See Merit In Novartis' Wet AMD Drug?
Company: Novartis AG NVS
Type of Application: BLA
Candidate: Brolucizumab
Indication: wet age-related macular degeneration, or AMD
Date: Oct. 15 (Estimated, based on the submission filing date of April 15)
See also: AzurRx Shares Tank On Unimpressive Efficacy Data For Biologic Drug To Treat Pancreatic Insufficiency
Second Label Expansion In The Cards For Amgen's Nplate?
Company: Amgen, Inc. AMGN
Type of Application: sBLA
Candidate: Nplate
Indication: treatment of adult patients with immune thrombocytopenia for 12 months or less
Date: Oct. 18 (Estimated, based on the submission filing date of Dec. 19)
Nplate was approved in 2008 as a long-term treatment of adults with chronic immune thrombocytopenia, or low platelet count. Later, Nplate was approved for pediatric patients with the same indication.
Go Or No-Go For Clearside's Macular Edema Drug?
Company: Clearside Biomedical Inc CLSD
Type of Application: NDA
Candidate: Xipere
Indication: treatment of macular edema associated with uveitis
Date: Oct. 19
Xipere, chemically triamcinolone acetonide ophthalmic suspension, is formulated as suprachoroidal Injection for the treatment of macular edema associated with uveitis.
Assertio Seeks Assent For Adrenocortical Insufficiency Diagnostic Drug
Company: Assertio Therapeutics Inc ASRT
Type of Application: NDA
Candidate: Cosyntropin
Indication: Diagnostic drug for detecting adrenocortical insufficiency
Date: Oct. 19
Long-acting cosyntropin is an alcohol-free formulation of a synthetic analogue of adrenocorticotropic hormone. It's secreted by the pituitary gland and is responsible for the stimulation of the adrenal cortex. Contingent on FDA approval, the company expects to launch the product in the U.S. by early 2020.
Can Alexion's Ultra-Rare Disease Drug Snag Second Approval?
Company: Alexion Pharmaceuticals, Inc. ALXN
Type of Application: sBLA
Candidate: Ultomiris
Indication: Atypical hemolytic uremic syndrome, or aHUS
Date: Oct. 19
aHUS, also known as complement-mediated thrombotic microangiopathy, is a severe and chronic ultra-rare disease that can cause progressive damage to vital organs, predominantly the kidneys, leading to kidney failure and premature death.
Ultomiris was previously approved in December 2018 for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.
Can Foamix Acne Treatment Clear FDA Hurdle?
Company: Foamix Pharmaceuticals Ltd FOMX
Type of Application: NDA
Candidate: FMX101
Indication: treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years and older
Date: Oct. 20
Eton Braces For Decision On Ready-to-use Phenylephrine
Company: Eton Pharmaceuticals Inc ETON
Type of Application: NDA
Candidate: ET-202
Indication: ready-to-use injectable formulation of phenylephrine
Date: Oct. 21
Melinta On Track For Another Approval For Antibacterial Drug?
Company: Melinta Therapeutics Inc NASDAQ: MLNT) and Ligand Pharmaceuticals Inc. LGND
Type of Application: sNDA
Candidate: Baxdella
Indication: community-acquired bacterial pneumonia, or CABP
Date: Oct. 24
BAXDELA, in both capsule and IV formulations, was approved by the FDA in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.
GlaxoSmithKline's Ovarian Cancer Drug to Add Another Indication?
Company: GlaxoSmithKline plc GSK
Type of Application: sNDA
Candidate: Zejula
Indication: Ovarian cancer
Date: Oct. 24
Zejula, or niraparib, came into Glaxo's stable following its acquisition of Tesaro.
Glaxo is now seeking approval of Zejula for the treatment of advanced ovarian, fallopian tube or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either BRCA mutation or homologous recombination deficiency.
Previously, Zejula was approved as a maintenance treatment of women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Adamis' Opioid Overdose Drug Awaits Clearance
Company: Adamis Pharmaceuticals Corp ADMP
Type of Application: NDA
Candidate: Higher-dose naloxone intramuscular injection
Indication: opioid overdose
Date: Oct. 31
Adamis recently said it was conducting additional pharmacokinetic studies comparing its long-acting naloxone injection, provisionally given the name Zimhi, to a relevant comparator. The company said it will forward data from the study to the FDA later this month.
Adcom Schedule
FDA's Antimicrobial Drugs Advisory Committee will meet Wednesday, Oct. 16 to discuss SHIONOGI & CO L/ADR SGIOY's NDA for cefiderocol lyophilized powder for intravenous administration for the treatment of complicated urinary tract infection, including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options.
The Bone, Reproductive and Urologic Drug Advisory Committee is scheduled to meet on Tuesday, Oct. 29 to discuss AMAG Pharmaceuticals, Inc. AMAG's sNDA for Makena, which is being evaluated for reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity.
The same committee will discuss Wednesday, Oct. 30 Agile Therapeutics Inc AGRX's NDA for Twirla — a low-dose combo hormonal contraceptive patch — to be used for birth control
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