Medication Monitor

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Generic Name (Trade Name—Company)
  • March 13, 2019

    Aerie Pharmaceuticals announced FDA approval of netarsudil and latanoprost ophthalmic solution 0.02%/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

    The once-daily eyedrop is a fixed-dose combination of latanoprost, the most widely prescribed prostaglandin analog (PGA), and netarsudil, the active ingredient in netarsudil ophthalmic solution 0.02% (Rhopressa), a first-in-class Rho kinase (ROCK) inhibitor specifically designed to target the trabecular meshwork (the eye’s principal drainage pathway). The diseased trabecular meshwork is considered to be the main cause of elevated IOP in open-angle glaucoma and ocular hypertension.

    Netarsudil works by restoring outflow through the trabecular meshwork, while latanoprost increases fluid outflow through a secondary mechanism known as the uveoscleral pathway.

    Approval was based on data from two Phase III registration trials, in which the agent achieved its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, demonstrating statistically superior IOP reduction over latanoprost and netarsudil at every measured timepoint.

    Treatment was associated with generally mild and tolerable ocular adverse events, with minimal systemic side effects. The most common ocular adverse event in controlled clinical studies was conjunctival hyperemia. Ninety percent of patients who experienced hyperemia reported it as mild, and 5% discontinued because of it.

    Other common ocular adverse effects were instillation-site pain, corneal verticillata, and conjunctival hemorrhage.

    Aerie plans to launch the new product in the United States in the second quarter of 2019.

  • March 13, 2019

    Regeneron and Sanofi announced FDA approval of dupilumab for patients aged 12 to 17 years with moderate to severe atopic dermatitis (eczema) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

    The agent is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation that underlies atopic dermatitis and several other allergic diseases.

    Dupixent has been studied in more than 7,000 patients aged 12 years and older in more than 30 clinical trials. Its safety profile in the adolescent trial was similar to the safety profile from trials in adults with atopic dermatitis and consistent through 52 weeks.

    The most common adverse events were injection-site reactions; eye and eyelid inflammation, including redness, swelling; and itching; oropharyngeal pain; and cold sores in the mouth or on the lips.

    Dupixent comes in two doses (200 mg and 300 mg), each as a prefilled syringe. Dupixent is intended for S.C. injection and is given every other week following an initial loading dose. It can be given in a clinic or, for convenience, at home by self-administration after training by a health professional.

    Dupixent is also approved for treatment of adult patients with moderate to severe atopic dermatitis that is not well controlled with topical prescription drugs or who cannot use topical therapies; and for use with other asthma medications for maintenance treatment of moderate to severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines.

  • March 13, 2019

    FDA granted accelerated approval to atezolizumab plus chemotherapy (nab-paclitaxel [Abraxane]) for treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TBNC) whose tumors express PD-L1, as determined by an FDA-approved test.

    Accelerated approval was based on data from a Phase III study demonstrating that atezolizumab plus nab-paclitaxel significantly reduced the risk of disease worsening or death by 40% compared with nab-paclitaxel alone in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. 

    The most common adverse effects of atezolizumab plus nab-paclitaxel were low white blood cell count, tingling or numbness in the hands and feet, decreased neutrophil count, fatigue, low red blood cell count, low blood potassium levels, pneumonia, and increased AST levels.

  • March 13, 2019

    Pfizer announced FDA approval of trastuzumab-qyyp, a biosimilar to trastuzumab (Herceptin), for treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

    Approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between trastuzumab-qyyp and trastuzumab. This includes results from the REFLECTIONS B327-02 clinical comparative study recently published in the British Journal of Cancer, which showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between trastuzumab and the originator product in patients with first-line, HER2-overexpressing metastatic breast cancer.

    Trastuzumab is a monoclonal antibody biosimilar that targets HER2, a protein found on the surface of some cancer cells that can stimulate the cells to divide and grow. The agent locks on to the HER2 protein and blocks the receptors, stopping cell division and growth.

  • March 13, 2019

    FDA approved a new generic valsartan in response to a recent shortage resulting from multiple recalls of generic valsartan products from several manufacturers after certain lots of valsartan and other ARB medicines were found to contain nitrosamine impurities.

    The agency is also working closely with manufacturers to see if they can produce additional supplies of these medications. FDA scientists are using the information learned from an investigation to evaluate all ARBs currently on the market and will also apply this information when assessing future applications to ensure that the manufacturing process can’t form these impurities.

    For this approval, FDA evaluated the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the new generic valsartan does not contain NDMA or NDEA. FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.

    FDA continues to investigate ARB medicines that contain nitrosamine impurities and that do not meet the agency’s quality standards. The agency will continue to update the lists on its website of recalled valsartan, losartan, and irbesartan products as more information becomes available from ongoing testing. If patients take an ARB drug product, they should check the lists periodically, as information may change. Not all ARB medicines have been recalled.

    Valsartan treats high blood pressure and heart failure. Its most common adverse effects are dizziness, hypotension, hyperkalemia, and increased blood creatinine.