A number of novel drugs are expected to gain FDA approval in 2020—and one of them has already been approved, weeks before the New Year. The FDA approved 53 new drugs this year, including 20 with indications related to oncology. *The listed “FDA-approved use” on this website is for presentation purposes only. Approval for both meds were supported by phase 3 clinical trials. The company plans to seek FDA approval to include this indication to the drug’s usage. The US Food and Drug Administration has approved the use of the drug tucatinib, or Tukysa, in combination with chemotherapy, for the treatment of … Encorafenib On April 8, 2020, the FDA cleared encorafenib plus cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) harboring a BRAF V600E mutation, detected by an FDA-approved test, following prior therapy. Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA … Previously approved medications that have gained new FDA approval for the treatment of additional medical conditions. The R&D crown for greatest success at the FDA in 2019 is going to have to be shared. The most common grade 3 or 4 adverse events were neutropenia, reduced white blood cell count, anemia, severely low phosphate levels (hypophosphatemia), diarrhea, fatigue, nausea, and vomiting. While the FDA approved a number of therapeutic agents for patients with rheumatologic diseases in 2020, safety signals such as angioedema and … Among those who responded, 24 patients (63%) had a response lasting 6 months or longer and 7 patients (18%) had a response lasting 12 months or longer. Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities - May 13, 2020 Imcivree (setmelanotide) FDA … During the clinical trial, patients received a daily pemigatinib tablet for 14 consecutive days, followed by 7 days off, in 21-day cycles. Each year, CDER approves a wide range of new drugs and biological products: Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. The FDA is approving more and more drugs every year—and 2020 appears to be no exception. Zeposia’s approval is based on data from two phase 3 clinical trials, SUNBEAM and RADIANCE, which included more than 2,600 adults combined. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information (click on the Drug Name) . Innovation drives progress. Esperoct is the trade name for glycopegylated-antihemophilic factor approved by the FDA in February 2019. After approval, FDA follow-up continues to make sure new drugs continue to be safe and effective. © 2021 M3 USA Corporation. Nexletol and Nexlizet for high cholesterol. Imfinzi (durvalumab) Injection New Dosage Regimen: November 18, 2020 Date of Original Approval: May 1, 2017 In late November—at least 3 months earlier than expected— the FDA approved a drug to treat sickle cell disease. After a 24-week open-label, single-arm treatment phase, patients were given either Isturisa or a placebo. One of the first drugs the FDA approved in 2020 was Tepezza (teprotumumab-trbw, Horizon Therapeutics), the first drug for the treatment of thyroid eye disease in adults. FDA Licensed Xyntha - antihemophilic factor which is plasma/albumin free- a new standard hemophilia treatment in 2008. Before sharing sensitive information, make sure you're on a federal government site. But according to the FDA, the outbreak has not slowed the regulatory drug approval process. The drug showed its efficacy in a phase 2, single-arm multicenter trial that enrolled 108 patients with metastatic triple-negative breast cancer who had received a median of 3 previous treatments for metastatic disease. The drug demonstrated an overall response rate (ORR) of 33.3% (95% CI: 24.6% to 43.1%) with a median response duration of 7.7 months (95% CI: 4.9-10.8). In mid-April, the FDA OK’d Pemazyre (pemigatinib, Incyte Corporation), the first approved treatment for adults with certain types of previously treated advanced cholangiocarcinoma—a rare form of cancer that forms in bile ducts. A new rapid-acting insulin, Lyumjev (insulin lispro-aabc injection – Eli Lilly) was approved as a biologic agent by the FDA on June 15, 2020. 04/17/2020 TUKYSA NDA #213411 TUCATINIB Type 1 - New Molecular Entity Priority SEAGEN 04/17/2020 PEMAZYRE NDA #213736 PEMIGATINIB Type 1 - New Molecular Entity Priority INCYTE CORP 04/22/2020 04/24 It provides 1.6-fold half-life prolongation in adults and adolescents and 1.9-fold half-life prolongation in children, compared to standard half-life factor VIII products. So far, the agency has approved 16 new drugs in 2020. Nurtec ODT (rimegepant, Biohaven) was approved by the FDA only 2 months ago—but there’s already a new development. Of those who received the study drug, 71% to 83% of patients in both studies had > 2-mm reduction in proptosis compared with 10% to 20% who received placebo. Here’s a roundup of the novel drugs that all doctors should know about: Nexletol and Nexlizet for high cholesterol In late February, the FDA approved two unique non-statin For both drugs, adverse events were mild to moderate in severity and comparable to those reported in patients on placebo. Reyvow is unique in that it is the first FDA-approved medication in a new class of acute migraine treatments known as serotonin (5-HT)1F receptor agonists. In a randomized phase 3 clinical trial, 21% of patients given Nurtec ODT had freedom from pain after 2 hours compared with 11% given a placebo. Median progression-free survival was 5.5 months (95% CI: 4.1-6.3) and overall survival was 13.0 months (95% CI: 11.2-13.7). For Immediate Release: June 11, 2020 The U.S. Food and Drug Administration today approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of … Cushing disease is a rare condition in which the adrenal glands produce too much cortisol. Orgovyx was approved … Objective To characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs. Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. The FDA approved Eli Lilly’s Reyvow (lasmiditan) for acute treatment of migraine with or without aura, and it is expected to be available in January 2020. Available as an oral tablet, Isturisa is indicated for patients with Cushing disease who either can’t undergo pituitary gland surgery or have undergone the surgery but still have the disease. See Drugs@FDA for information about all of CDER’s approved drugs and biological products. 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