FDA Panel Conducts Safety Review of Gadolinium Retention in the Brain from Gadolinium Based Contrast Agents

Posted by on November 27, 2017

On September 8th, the Medical Imaging Drugs Advisory Committee (MIDAC) discussed the potential risk of systemic gadolinium retention, especially in the brain, in patients receiving gadolinium-based contrast agents (GBCAs) used for magnetic resonance imaging (MRI) diagnostic procedures. This was a multi-sponsor meeting, which included Bayer Healthcare, Bracco Diagnostics, GE Healthcare, and Guerbet. The meeting began
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FDA Advisory Committee Votes Negatively on Safety and Effectiveness of Bayer’s Ciprofloxacin Inhalation Powder

Posted by on November 27, 2017

The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) convened on November 16th to discuss ciprofloxacin inhalation powder (NDA 209367), sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis (CF) bronchiectasis (NCFB) in adult patients (≥18 years of age) with respiratory bacterial pathogen. Ciprofloxacin is a synthetic, fluorinated carboxyquinolone
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FDA Advisory Committee Makes Recommendations for Pfizer Staph Vaccine Trial

Posted by on November 26, 2017

On November 7th, the Vaccines and Related Biological Products Committee (VRBPAC) met to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine (SA4Ag) intended for pre-surgical prophylaxis in elective orthopedic surgical populations. Specifically, the FDA sought the committee’s input regarding the clinical data necessary to support the indication. The
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FDA Advisory Committee Recommends Approval of Two Buprenorphine Products for the Treatment of Opioid Use Disorder

Posted by on November 25, 2017

The Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) convened on October 31st and November 1st to discuss two buprenorphine subcutaneous injections for treatment of opioid dependence. On October 31st the joint committee discussed buprenorphine subcutaneous injection (RBP-600; NDA 209819), submitted by Indivior Pharmaceuticals, Inc. and on the
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FDA Advisory Committee Recommends Approval of Novo Nordisk’s Type 2 Diabetes Drug, Semaglutide

Posted by on November 24, 2017

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on October 18th, to discuss the safety and efficacy of semaglutide injection (NDA 209637) submitted by Novo Nordisk. The proposed indication is to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. The committee first discussed the
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FDA Advisory Committee Votes in Favor of Rhopressa™

Posted by on November 23, 2017

On October 13th, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) discussed the new drug application (NDA 208254) for Rhopressa™ (netarsudil ophthalmic solution) 0.02%, submitted by Aerie Pharmaceuticals Inc. The proposed indication for Rhopressa is to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). There were 2 voting
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FDA Advisory Committee Unanimously Votes in Support of the Approval of GSK Shingles Vaccine

Posted by on November 22, 2017

The FDA’s Vaccines and Related Biological Products Committee (VRBPAC) met on September 13th to discuss and make recommendations on the safety and effectiveness of Zoster Vaccine Recombinant (Adjuvanted) -Shingrix™, manufactured by GlaxoSmithKline Biologicals (GSK). The committee voted unanimously (11 Yes, 0 No, 0 Abstain) that the data was adequate to support both the safety and
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FDA Advisory Committee Unanimously Recommends Approval of LUXTURNA for Patients with Biallelic RPE65-mediated Inherited Retinal Disease

Posted by on November 21, 2017

On October 12th, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) met to discuss and make recommendations on the safety and effectiveness of the Biologics License Application (BLA 125610) for LUXTURNA™ (voretigene neparvovec), submitted by Spark Therapeutics, Inc. The proposed indication is treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated
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FDA Panel Votes Data Are Inconclusive For Approval of Ataluren® For Treatment Of Patients With Dystrophinopathy

Posted by on November 20, 2017

The Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee met on September 28th to discuss the new drug application (NDA 200896) for Ataluren®. Ataluren, sponsored by PTC Therapeutics, Inc, is a novel, orally administered small-molecule compound for the treatment of patients with genetic disorders due to a nonsense mutation in the dystrophin gene. Dystrophinopathies
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Split Decision from FDA Advisory Committee on Approval for Sutent® In Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery

Posted by on November 16, 2017

On September 19th the Oncologic Advisory Committee (ODAC) discussed supplemental new drug application (sNDA 021938/033) for SUTENT® (sunitinib malate) oral capsules, submitted by C.P. Pharmaceuticals International C.V., and represented by authorized US agent, Pfizer, Inc. The proposed indication for this product is as an adjuvant treatment of adult patients at high risk of recurrent renal
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