Triclabendazole

This is a list of new molecular entities and new therapeutic biological products approved by the agency’s Center for Biologics Evaluation and Research in 2019. The U.S. Food and Drug Administration (FDA) oversees and approves a wide range of medical products each year. Many approvals are for previously approved drugs for new indications. Others are for new molecular entities and new therapeutic biological products. Below is a list of new molecular entities and new therapeutic biological products approved by the agency’s Center for Biologics Evaluation and Research in 2019. The list does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved this year. Evolus’ Jeuveau (prabotulinumtoxinA-xvfs). For temporary improvement of moderate to severe glabellar lines (frown lines). Sanofi Genzyme’s Cablivi (caplacizumab-yhdtp). For adults with acquired thrombotic thrombocytopenic purpura (aTTP). Novartis’ Egaten (triclabendazole). For fascioliasis, a parasitic infestation caused by two types of flatworms. Sage Therapeutics’ Zulresso (brexanolone). For postpartum depression. Jazz Pharmaceuticals’ Sunosi (solriamfetol). For excessive sleepiness in adults with narcolepsy or obstructive sleep apnea. Novartis’ Mayzent (siponimod). For adults with relapsing forms of multiple sclerosis (MS). Amgen’s Evenity (romosozumab-aqqg). For osteoporosis in postmenopausal women at high risk of fracture. Janssen’s Balversa (erdafitinib). For adults with locally advanced or metastatic bladder cancer. AbbVie’s Skyrizi (risankizumab-rzaa). To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Pfizer’s Vyndaqel (tafamidis meglumine). For heart disease caused by transthyretin mediated amyloidosis (ATTR-CM). Novartis’ Piqray (alpelisib). For breast cancer. Genentech’s Polivy (polatuzumab vedotin-piiq). For adults with relapsed/refractory (r/r) diffuse large B-cell lymphoma. AMAG Pharmaceuticals’ Vyleesi (bremelanotide). For hypoactive sexual desire disorder in premenopausal women. Karyopharm Therapeutics’ Xpovio (selinexor). For adults with r/r multiple myeloma (RRMM). Merck’s Recarbrio (imipenem, cilastatin and relebactam). To treat complicated urinary tract and complicated intra-abdominal infections. Shield Therapeutics’ Accrufer (ferric maltol). For iron deficiency anemia in adults. Bayer’s Nubeqa (darolutamide). For adults with nonmetastatic castration resistant prostate cancer. Daiichi Sankyo’s Turalio (pexidartinib). For adults with symptomatic tenosynovial giant cell tumor. TB Alliance’s Pretomanid. An antibiotic to treat resistant forms of tuberculosis that affects the lungs. Harmony Biosciences’ Wakix (pitolisant) . For excessive daytime sleepiness (EDS) in adults with narcolepsy. Genentech’s Rozlytrek (entrectinib). For adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive and for adult and pediatric patients 12 years of age and older with solid tumors. Celgene Corporation’s Inrebic (fedratinib). For adults with intermediate-2 or high-risk primary or secondary myelofibrosis. AbbVie’s Rinvoq (upadacitinib). For adults with moderately to severely active rheumatoid arthritis. Nabriva Therapeutics’ Xenleta (lefamulin). To treat adults with community-acquired bacterial pneumonia. University of Iowa Health Care’s Ga-68-DOTATOC. For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs). Kyowa Kirin’s Nourianz (istradefylline). To treat adults with Parkinson’s disease experiencing OFF episodes. Ardelyx’s Ibsrela (tenapanor). For irritable bowel syndrome with constipation in adults. Galderma’s Aklief (trifarotene). For acne vulgaris in patients 9 years of age and older. Novartis’ Beovu (brolucizumab-dbll). To treat wet age-related macular degeneration. Clinuvel’s Scenesse (afamelanotide). To increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. The Feinstein Institutes for Medical Research’s Fluorodopa F 18. A diagnostic agent for use in PET to help diagnose adults with suspected Parkinsonian syndromes (PS). Eli Lilly’s Reyvow (lasmiditan). To treat acute migraine with or without aura, in adults. Vertex Pharmaceuticals’ Trikafta (elexacafator/ivacaftor/tezacaftor). To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis (CF). IQ Medical Ventures’ ExEm Foam (air polymer-type A). A diagnostic agent used to assess fallopian tube openness in women with known or suspected infertility. Celgene Corporation’s Reblozyl (luspatercept-aamt). To treat anemia in adults with beta thalassemia who require regular red blood cell transfusions. BeiGene’s Brukinsa (zanubrutiib). For patients with mantle cell lymphoma. Shionogi & Co.’s Fetroja (cefiderocol). For patients with complicated urinary tract infections who have limited or no alternative treatment options. Novartis’ Adakveo (crizanlizumab-tmca). For patients with painful complication of sickle cell disease. Alnylam Pharmaceuticals’ Givlaari (givosiran). For acute hepatic porphyria. SK Biopharma’s Xcopri (cenobamate). For partial onset seizures. Global Blood Therapeutics’ Oxbryta (voxelotor). For sickle cell disease. Sarepta Therapeutics’ Vyondys 53 (golodirsen). For certain patients with Duchenne muscular dystrophy (DMD). Seattle Genetics’ Padcev (enfortumab vedotin-ejfv). For refractory bladder cancer. Dutch Ophthalmic Research Center (DORC)’s TissueBlue (Brilliant Blue G Ophthalmic Solution). Dye used in eye surgery. Intra-Cellular Therapies’ Caplyta (lumateperone tosylate) . To treat schizophrenia. Eisai Co.’s Dayvigo (lemborexant). To treat insomnia. AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki). To treat metastatic breast cancer. Allergan’s Ubrelvy (ubrogepant) . For acute treatment of migraine with or without aura in adults. hbspt.forms.create({ portalId: "4413123", formId: "c4dda430-e2b0-4083-86f3-ccce0c1d4479" });

Novartis announced that the FDA approved the company’s Egaten to treat fascioliasis in patients six years of age and older. Novartis also inked a multi-target and multi-year collaboration with AbCellera. In a busy day, Novartis announced that the U.S. Food and Drug Administration (FDA) approved the company’s Egaten (triclabendazole) to treat fascioliasis in patients six years of age and older. Fascioliasis is a neglected tropical disease otherwise known as a liver fluke infestation. It infects 2.4 million people globally with another 180 million expected to be at risk. The disease is caused by two species of parasitic flatworms, Fasciola hepatica or Fasciola gigantica . They infect people after consuming larvae in contaminated water or food. “Novartis has a long-standing commitment to addressing global health challenges and supporting disease elimination efforts, in diseases such as leprosy, malaria and fascioliasis,” stated Vas Narasimhan, Novartis’ chief executive officer. “Today’s FDA approval of Egaten is another important milestone that we believe will help further expand access.” Egaten is the only drug for fascioliasis recommended by the World Health Organization (WHO). WHO plans to provide the drug during epidemic outbreaks in addition to periodic use in endemic countries. It is also on the WHO Model List of Essential Medicines. If untreated, the disease causes considerable pain and discomfort. The acute phase of the disease is marked by fever, abdominal pain, nausea, diarrhea and eosinophilia. It can progress into a chronic or obstructive phase. Novartis has been donating the drug to the WHO since 2005. In 2018, the company renewed its deal with the WHO to extend the drug donation until 2022. Novartis is a signatory to the London Declaration on Neglected Tropical Diseases. This declaration has a goal of controlling, eliminating or eradicating 10 diseases by 2020. “This FDA decision is welcome news for millions who suffer or are at risk of fascioliasis and removes a major hurdle in expanding treatment to countries where it is most needed,” stated Mwelecela Malecela, director of the Department of Control of Neglected Tropical Diseases at the WHO. “We are thankful to Novartis for their sustained decade-long commitment in tackling yet another disease of poverty.” In other news, Novartis inked a multi-target and multi-year collaboration with Vancouver, British Columbia-based AbCellera . Under the deal, AbCellera provides its expertise in antibody discovery as well as its single-cell screening technology to advance programs for up to 10 targets chosen by Novartis. AbCellera is eligible to receive access to technology, research funding, downstream milestone payments, and royalties on net product sales. In the last three years, AbCellera has completed more than 30 antibody discovery deals, including agreements with seven global pharma companies and “top-tier public and venture-backed biotech companies.” Other companies include GlaxoSmithKline, Merck & Co., and Pfizer. AbCellera’s platform scours immune responses to identify naturally derived antibodies. AbCellera currently has 72 full-time staffers and expects to add almost 30 by the end of this year. It recently moved into a new 22,000-square-foot laboratory. “AbCellera continues to build its reputation as a high-powered innovation shop and the premier provider for therapeutic antibody discovery from natural immune responses,” stated Carl Hansen, president and chief executive officer of AbCellera. “This partnership with Novartis marks an important evolution of our partnering strategy, expanding form target-based collaborations to deal structures that encourage long-term relationships and provide extended technology access to select partners.”