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Newest Drug Approvals

The FDA has recently approved the following medications:

Brineura from BioMarin was approved in April for the treatment of late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). This fatal genetic neurodegenerative disease affects 1 in 12,500 live births and  Brineura is specifically indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with with late CLN2 and is indicated to improve the quality of life of the young patients.

For the treatment of adult patients with newly diagnosed acute myeloid leukemia and mastocytosis who are FLT3 positive, Rydapt from Novartis was approved in April 2017. Rydapt is specifically indicated to work in combination with certain chemotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are FLT3 mutation positive. It is also indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia.

Patients with ocular itching associated allergic conjunctivitis, Zerviate from NicOx was approved by the FDA. This topical antihistamine reduces swelling, itching and, and dilation of blood vessels in the eye.

Kevara from Sanofi was approved in May for the treatment of active rheumatoid arthritis.

Kevzara is specifically indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). Kevzara may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs. The recommended dosage of Kevzara is 200 mg once every two weeks, administered as a subcutaneous injection.

Postmenopausal women with osteoporosis at a high risk of fracture or have a history of osteoporatic fracture, have a new treatment in Tymlos from Radius Health. Tymols was approved in April and is a human parathyroid hormone related peptide analog. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. It is not recommended taking Tymlos and parathyroid hormone analogs for more than two years during a patient’s lifetime.

Austedo from Teva Pharmaceuticals was approved in April for the treatment of chorea associated with Huntington’s disease. Dosage is determined individually for each patient based on the reduction of chorea and their tolerability. Austedo is supplied in pill form and must be swallowed whole and must be taken with food.

For those suffering from tardive dyskinesia, Ingrezza from Neurocrine Biosciences was approved in April. Targive dyskinesia is a chronic disorder of the nervous system characterized by involuntary jerky movements of the face, tongue, jaws, trunk, and limbs, usually developing as a late side effect of prolonged treatment with antipsychotic drugs.

Radicava from Mitsubishi Tanabe Pharma was approved in May for the treatment of amyotrophic lateral sclerosis (ALS). This incurable disease is the progressive degeneration of motor neurons in the brain stem and spinal cord leads to atrophy and eventually complete paralysis of the voluntary muscles.

Alunbrig from Ariad Pharmaceutical was approved in April for the treatment of advanced ALK-positive metastatic non-small cell lung cancer.

Alunbrig is specifically indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on, or are intolerant to, the anti-cancer drug, crizotinib.

For those patients with advanced or metastatic urothelial carcinoma, Imfinzi from AstraZeneca was approved in May. The urothelium is a type of thin tissue that lines much of the urinary tract including the renal pelvis, the ureters, the bladder, and parts of the urethra.

Imfinzi is specifically indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • have disease progression during or following platinum-containing chemotherapy.
  • have disease progression within 12 months of the first treatment or adjuvant treatment with platinum-containing chemotherapy

As with any medication, there are side-effects. Consult with your doctor about these new treatments to see if they are right for you. Talk to your pharmacist to make sure any new drug that you take does not interfere with your current medications.

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