Medication Monitor

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Generic Name (Trade Name—Company)
  • July 24, 2019

    Samsung Bioepis announced FDA approval of adalimumab-bwwd, a biosimilar of adalimumab (Humira), for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. 

    FDA approval was based on data derived from a randomized, double-blind, 52-week Phase III study in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy were randomized to receive either adalimumab-bwwd or the adalimumab reference product (ADL).

    At week 24, the ACR20 response rate was 72.4% in the adalimumab-bwwd group versus 72.2% in the ADL group. The safety profile of adalimumab-bwwd was comparable to ADL up to week 24. At week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transition to adalimumab-bwwd, and 254 patients receiving adalimumab-bwwd continued to receive adalimumab-bwwd.

    Up to week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment-emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.

    Patients treated with adalimumab products, including adalimumab-bwwd, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to other opportunistic pathogens. 

    Adalimumab-bwwd should be discontinued if a patient develops a serious infection or sepsis. Patients also should be tested for latent tuberculosis before use and during therapy, and treated initiated for latent tuberculosis before use.

    Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers, including adalimumab products.

    Warnings include serious infections, malignancies, hypersensitivity reactions including anaphylaxis and angioneurotic edema, Hepatitis B virus reactivation, neurologic and hematological reactions, use with Anakinra, heart failure, autoimmunity, immunizations, and use with Abatacept.

    Adalimumab-bwwd is expected to launch in the United States after June 30, 2023.

  • July 24, 2019

    Pfizer announced FDA approval of rituximab-pvvr, a biosimilar to rituximab (Rituxan) for treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

    Approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of rituximab-pvvr to the reference product. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety, and immunogenicity, pharmacokinetics, and pharmacodynamics of rituximab-pvvr. The study found no clinically meaningful differences in safety or efficacy compared with the reference product in patients with CD20-positive, low tumor burden follicular lymphoma.

    Boxed warnings include fatal infusion-related reactions, severe mucocutaneous reactions, and hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy.

    The most common adverse reactions (incidence ≥25%) in clinical trials of NHL and CLL were infusion-related reactions. In addition, fever, lymphopenia, chills, infection, and asthenia were seen in NHL trials; and neutropenia was seen in CLL trials.

  • July 24, 2019

    On July 19, FDA approved multiple applications for first generics of Lyrica (pregabalin) for management of neuropathic pain associated with diabetic peripheral neuropathy, for management of postherpetic neuralgia, for management of fibromyalgia, for management of neuropathic pain associated with spinal cord injury, and as an adjunctive therapy for treatment of partial-onset seizures in patients ages 17 years and older. 

    Pregabalin must be dispensed with a patient Medication Guide that contains important information about its uses and risks. Warnings include the risk of angioedema, which may be associated with life-threatening respiratory compromise requiring emergency treatment.

    Hypersensitivity reactions such as hives, difficulty breathing, and wheezing can occur. Increased seizure frequency or other adverse reactions may occur if the drug is rapidly discontinued. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. In addition, pregabalin may cause peripheral edema, so caution should be exercised when coadministering it with thiazolidinedione antidiabetic agents.

    Pregabalin also may cause dizziness and drowsiness and impair ability to drive or operate machinery.

    The most common adverse effects in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking (primarily difficulty with concentration and attention).

    FDA granted approvals for the generic versions of Lyrica to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

  • July 24, 2019

    Celgene Corporation announced FDA approval of apremilast 30 mg twice daily for treatment of adult patients with oral ulcers associated with Behçet’s Disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat. The drug is an oral, selective inhibitor of phosphodiesterase.

    Approval was based on efficacy and safety results from the RELIEF trial, a randomized, placebo-controlled, double-blind study evaluating the use of apremilast in adult patients with Behçet’s Disease who had active oral ulcers and were previously treated with at least one nonbiologic medication and were candidates for systemic therapy.

    Results showed that use of apremilast 30 mg resulted in a 42.7 point reduction from baseline in the pain of oral ulcers as measured by the visual analog scale at week 12, compared with an 18.7 point reduction with placebo. The proportion of patients achieving an oral ulcer complete response (oral ulcer-free) at week 12 was 52.9% in the apremilast arm and 22.3% in the placebo arm.

    The proportion of patients achieving oral ulcer complete response by week 6 and who remained oral ulcer-free for at least 6 additional weeks during the 12-week treatment phase was 29.8% in the apremilast arm and 4.9% in the placebo arm. The daily average number of oral ulcers during the 12-week treatment phase was 1.5 in the apremilast arm and 2.6 in the placebo arm (based on oral ulcer counts measured at baseline and at weeks 1, 2, 4, 6, 8, 10, and 12).

    The most common adverse events were diarrhea, nausea, headache, and upper respiratory tract infection.

  • July 17, 2019

    Zydus Cadila announced FDA approval of misoprostol tablets, a generic of Cytotec, 100 mcg and 200 mcg to prevent stomach ulcers in patients taking pain medications, especially if the patient is at risk for developing ulcers or has a past history of ulcers.

    Misoprostol helps to decrease risk of serious ulcer complications such as bleeding.