The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
| Organization: | FDA |
|---|---|
| Category: | Governmental Organizations |
| URL: | https://www.fda.gov/ |
The US FDA has approved Verastem's new anticancer drug Duvelisib (Copiktra) for the treatment of adults who have undergone at least two previous treatments, relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Duvelisib also received accelerated approval for treatment of adult patients with relapsed or refractory follicular lymphoma.
Galcanezumab-gnlm (Emgality™; Eli Lilly and Company), hereafter galcanezumab, is a humanized monoclonal antibody against the calcitonin gene-related peptide (CGRP) ligand. A potent vasodilator, CGRP is implicated in nociceptive transmission and migraine pathogenesis. In September 2018, the US FDA approved galcanezumab as a once-monthly subcutaneous injection for the preventive treatment of migraine in adults. In the same month, the EMA issued a positive opinion for galcanezumab for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
Fremanezumab-vfrm (hereafter referred to as fremanezumab) [AJOVY™] is a fully humanized monoclonal antibody (IgG2Δa) developed by Teva Pharmaceuticals to selectively target calcitonin gene-related peptide (a vasodilatory neuropeptide involved in the pathophysiology of migraine).
September 13, 2018, The U.S. Food and Drug Administration today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.
2018.8.23, The U.S. Food and Drug Administration today approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the U.S. to treat patients 12 years and older with types I and II hereditary angioedema (HAE). HAE is a rare and serious genetic disease that affects people with low levels of and poorly functioning C1-INH proteins in the body. This results in recurrent, unpredictable episodes of severe swelling in different areas of the body, including the stomach, limbs, face and throat.
August 22, 2018, The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).
On August 20th, the US FDA announced the approval of Biocodex's Diacomit (stiripentol), which was used in combination with clobazam to treat seizures in patients with Dravet syndrome over 2 years of age. It is worth mentioning that this is also the 31st new drug approved by the US FDA.
August 10, 2018, The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation determined to be responsive (“amenable”) to treatment with Galafold based on laboratory data. Fabry disease is a rare and serious genetic disease that results from buildup of a type of fat called globotriaosylceramide (GL-3) in blood vessels, the kidneys, the heart, the nerves and other organs.
August 10, 2018, The U.S. Food and Drug Administration today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year. Annovera is a reusable donut-shaped (ring), non-biodegradable, flexible vaginal system that is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed).
August 10, 2018, The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart and other organs.
