Medication Monitor

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  • February 10, 2015

    FDA has expanded the approved use for ranibizumab injection 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).

    In 2008, 33% of adults with diabetes aged 40 years or older had some form of DR. In some cases of DR with DME, abnormal new blood vessels grow on the surface of the retina. Severe vision loss or blindness can occur if the new blood vessels break.

    The drug is administered by a physician as an injection into the eye once a month. It is intended to be used along with appropriate interventions to control blood glucose levels, blood pressure, and cholesterol.

    The drug’s safety and efficacy to treat DR with DME were established in two clinical studies involving 759 participants who were treated and followed for 3 years. In the two studies, participants being treated with ranibizumab showed significant improvement in the severity of their DR at 2 years compared with patients who did not receive an injection.

    The most common adverse effects include bleeding of the conjunctiva, eye pain, floaters, and increased pressure inside the eye. Serious adverse effects include infection within the eyeball and retinal detachments.

    FDA granted ranibizumab for DR with DME breakthrough therapy designation and also reviewed the new use under the agency’s priority review program, which provides for an expedited review of drugs that demonstrate the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.

    FDA previously approved ranibizumab to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula, resulting in blurred vision. Ranibizumab also is approved to treat neovascular age-related macular degeneration, a condition in which abnormal blood vessels grow and leak fluid into the macula.

  • February 2, 2015

    FDA has expanded the approved use of ibrutinib for patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use.

    A type of non-Hodgkin lymphoma, WM usually gets worse slowly over time and causes abnormal blood cells, B lymphocytes (B cells), to grow within the bone marrow, lymph nodes, liver, and spleen. In WM, abnormal B cells also overproduce immunoglobulin M or IgM (macroglobulin) that may lead to excess bleeding, vision problems, and nervous system problems.

    Ibrutinib works by blocking the enzyme that allows the abnormal B cells in WM to grow and divide.

    FDA initially granted ibrutinib accelerated approval in November 2013 for use in patients with mantle cell lymphoma who received one prior therapy. In February 2014, FDA granted accelerated approval to ibrutinib for use in patients with previously treated chronic lymphocytic leukemia (CLL) and then, in July 2014, expanded its use to include treatment of CLL patients who carry a deletion in chromosome 17.

    Approval of ibrutinib for WM was based on a clinical study of 63 previously treated participants who received a daily 420-mg, orally administered dose of the medication until disease progression or until adverse effects became intolerable. Results showed 62% of participants had their cancer shrink after treatment (overall response rate). At the time of the study, duration of response ranged from 2.8 months to approximately 18.8 months.

    The most common adverse effects associated with the drug are low blood platelet counts, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash.

    Health professionals should inform patients of the risk of hemorrhage, infections, abnormal heartbeat, development of new cancers, metabolic disturbances following treatment, and embryo-fetal toxicity associated with its use.

    FDA granted ibrutinib for WM breakthrough therapy designation, priority review, and orphan product designation because the company demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; has potential, at the time of the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively.

    The product’s new use is being approved more than 2 months ahead of its prescription drug user fee goal date of April 17, 2015, the date FDA was scheduled to complete review of the drug application.

  • November 24, 2015

    FDA approved ixazomib in combination with two other therapies to treat patients with multiple myeloma who have received at least one prior therapy.

    It is the third drug for multiple myeloma approved this year and provides patients with a new oral treatment that slows disease progression when other therapy has failed. FDA approved panobinostat (Farydak—Novartis) in February and daratumumab (Darzalex—Janssen Biotech) earlier in November.

    Ixazomib, first oral proteasome inhibitor, works by blocking enzymes from multiple myeloma cells, hindering their ability to grow and survive. It was approved in combination with another FDA-approved treatment for multiple myeloma: lenalidomide (Revlimid—Celgene Corporation) and dexamethasone, a type of corticosteroid.

    Safety and efficacy of ixazomib were demonstrated in an international, randomized, double-blind clinical trial of 722 patients whose multiple myeloma came back after, or did not respond to, previous treatment. Study participants received either ixazomib in combination with lenalidomide and dexamethasone or placebo plus lenalidomide and dexamethasone. Those taking ixazomib lived longer without their disease worsening (average 20.6 months) compared with participants taking the other regimen (14.7 months).

    The most common adverse effects of ixazomib are diarrhea, constipation, low blood platelet count, peripheral neuropathy, nausea, peripheral edema, vomiting and back pain.

    FDA granted priority review and orphan drug designations for ixazomib.

  • May 3, 2016

    FDA has approved pimavanserin tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson disease.

    Hallucinations or delusions can occur in as many as 50% of patients with Parkinson disease at some time during the course of their illness. 

    Effectiveness of pimavanserin was shown in a 6-week clinical trial of 199 participants. The drug was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson disease.

    As with other atypical antipsychotic drugs, pimavanserin has a boxed warning alerting health professionals about an increased risk of death associated with use of these drugs to treat older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

    In clinical trials, the most common adverse effects reported by participants taking pimavanserin were swelling, usually of the ankles, legs, and feet due to the accumulation of excessive fluid in the tissue; nausea; and abnormal state of mind (confused state).

    Pimavanserin was granted breakthrough therapy designation and a priority review.

  • April 7, 2016

    FDA has approved a second biosimilar, infliximab-dyyb, under the trade name Inflectra, for multiple indications. It is administered by I.V. infusion.

    Inflectra is biosimilar to Janssen Biotech's Remicade (infliximab), which was originally licensed in 1998. It was approved for the treatment of adult patients and pediatric patients (aged 6 years and older) with moderately to severely active Crohn disease who have had an inadequate response to conventional therapy; adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; patients with active ankylosing spondylitis (arthritis of the spine); patients with active psoriatic arthritis; and adult patients with chronic severe plaque psoriasis.

    FDA’s approval of Inflectra was based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrate Inflectra is biosimilar to Remicade. Inflectra has been approved as biosimilar, not as an interchangeable product.

    The most common expected adverse effects of Inflectra include respiratory infections, such as sinus infections and sore throat, headache, coughing, and stomach pain. Infusion reactions can happen up to 2 hours after an infusion. Symptoms of infusion reactions may include fever, chills, chest pain, low blood pressure or high blood pressure, shortness of breath, rash, and itching.  

    Inflectra contains a boxed warning about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and others. The boxed warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including infliximab products such as Inflectra.

    Other serious adverse effects may include liver injury, blood problems, lupuslike syndrome, psoriasis, and in rare cases, nervous system disorders.

    The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.