FDA Panel Recommends Icosapent Ethyl (Vascepa) for Cardiovascular Risk Reduction

Posted by on November 18, 2019

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on November 14th to review a supplemental New Drug Applications (sNDA) for icosapent ethyl, which is currently indicated for triglyceride reduction in patients in very high triglyceride levels. The meeting discussed the sNDA by the applicant Amarin Pharmaceuticals Ireland Limited, which would expand the label of
Read More

Panel Does Not Recommend Expanding the Indicated Population for Empagliflozin (Jardiance)

Posted by on November 18, 2019

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on November 13th to discuss the Boehringer Ingelheim Pharmaceuticals, Inc supplemental New Drug Application (sNDA) 204629/S-020 for empagliflozin. The sNDA seeks to expand the  indicated use of empagliflozin, 10-25mg/day, for glycemic control / cardiovascular risk reduction in patients with type-II diabetes to  include type-I diabetes as
Read More

FDA Panel Recommends Approval of Nintedanib for Systemic Sclerosis

Posted by on August 22, 2019

The Arthritis Advisory Committee (AAC) met on July 25th to review the supplemental New Drug Application (sNDA) 205832 for nintedanib capsules by the applicant: Boehringer Ingelheim.  The panel evaluated the proposed indication for treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). Systemic Sclerosis (SSc) is a rare, multisystem connective tissue disease. It creates microvascular damage
Read More

FDA Approves Selinexor Despite Panel’s Vote To Delay

Posted by on August 6, 2019

On February 26th, 2019, the Oncologic Drugs Advisory Committee assembled to determine the fate of Karyopharm Therapeutics’ latest drug, Selinexor (NDA 212306). Selinexor, an oral XPO1 inhibitor, is formulated to be used in combination with dexamethasone, for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and
Read More

FDA Advisory Committee in Favor of Mannitol Inhalation Powder

Posted by on July 29, 2019

On May 8th, 2019 the Pulmonary-Allergy Drugs Advisory Committee (PADAC) convened to review the new drug application (NDA) #202049 for Bronchitol (mannitol inhalation powder) sponsored by Chiesi USA, Inc. Bronchitol, an inhaled dry powder form of mannitol, is intended for the management of cystic fibrosis in adults to improve pulmonary function in conjunction with standard
Read More

Oncologic Drugs Advisory Committee Supports Pexidartinib but Not Quizartinib

Posted by on July 24, 2019

The Oncologic Drugs Advisory Committee (ODAC) reviewed the new drug application (NDA) #211810 for perxidartinib and NDA # 212166 for quizartinib by Daiichi Sankyo on May 14th, 2019. Pexidartinib was evaluated for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients.  The intended use of quizartinib was for the treatment of Feline
Read More

FDA Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Endorse Esketamine

Posted by on July 24, 2019

On February 12th, 2019, Janssen Pharmaceuticals, Inc. discussed their New Drug Application (NDA) #211243 for Esketamine nasal spray during a joint meeting of the FDA’s DSaRM and PDAC. The proposed indication is for the maintenance of treatment-resistant depression (TRD). The sponsor explained that TRD occurs when patients diagnosed with major depressive disorder (MDD) are unresponsive
Read More

FDA Joint Committee Recommends Approval of Uloric (Febuxostat) Tablets

Posted by on June 21, 2019

On January 11th, 2019, Takeda Pharmaceuticals appeared before a joint session of the Arthritis Advisory and the Drug Safety and Risk Management Advisory Committees. They were seeking approval for their supplemental new drug application for Uloric tablets (sNDA 021-856). Uloric, a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout,
Read More

FDA Endocrinology and Metabolic Drugs Advisory Committee Split on Approvability of Sotagliflozin Oral Tablet for Diabetes

Posted by on June 14, 2019

On January 17th, 2019, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) reviewed the New Drug Application (NDA) 210934 sotagliflozin (Sanofi-Aventis U.S., LLC.) which seeks approval of sotagliflozin as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus. Sotagliflozin is a dual inhibitor of sodium-glucose cotransporter 1 (SGLT1)
Read More

Pretomanid NDA for Drug-Resistant TB reviewed by FDA’s Antimicrobial Drugs Advisory Committee

Posted by on June 7, 2019

On June 6th, 2019, the Antimicrobial Drugs Advisory Committee convened to discuss the new drug application (NDA) # 212862 with the sponsor company: The Global Alliance for TB Drug Development, Inc. The NDA seeks approval of pretomanid (PA-824) in combination with the antibacterial drugs bedaquiline and linezolid for the treatment of drug-resistant or intolerant tuberculosis
Read More