Medication Monitor



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  • June 15, 2018

    FDA has approved moxidectin 8-mg tablets to treat river blindness (onchocerciasis) in patients aged 12 years and older. FDA has also awarded a priority review voucher (PRV) to the manufacturer, Medicines Development for Global Health (MDGH). 

    River blindness is caused by a parasitic worm, Onchocerca volvulus. The disease manifests as severe itching, disfiguring skin conditions, and visual impairment, including permanent blindness, caused by the worm’s larvae (microfilariae).

    Approval of moxidectin was based on data from two randomized, double-blind, active controlled clinical studies. Each study met its respective primary endpoints, showing a statistically significant superiority of moxidectin over the current standard of care, ivermectin, in suppressing the presence of the microfilariae in skin. Full results from the Phase III study were published in the Lancet in January 2018.

    Moxidectin is supplied as 2-mg tablets for administration as an 8-mg dose per oral to patients at least 12 years of age with O. volvulus infection.

  • June 9, 2018

    FDA granted regular approval to venetoclax for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

    Approval was based on MURANO, a randomized (1:1), multicenter, open-label trial of venetoclax with rituximab (VEN+R) versus bendamustine with rituximab (B+R) in 389 patients with CLL who had received at least one prior line of therapy. Patients in the VEN+R arm completed a 5-week ramp-up venetoclax schedule and then received venetoclax 400 mg once daily for 24 months measured from the rituximab start date.

    Rituximab was initiated after venetoclax ramp-up and given for six cycles (375 mg/m2 intravenously on cycle 1, day 1 and 500 mg/m2 intravenously on day 1 of cycles 2–6, with a 28-day cycle length). The comparator arm received six cycles of B+R (bendamustine 70 mg/m2 on days 1 and 2 of each 28-day cycle and rituximab at the above described dose and schedule).

    Efficacy was based on progression-free survival (PFS) as assessed by an independent review committee. After a median follow-up of 23 months, the median PFS was not reached in the VEN+R arm and was 18.1 months (95% CI 15.8–22.3) in the B+R arm (hazard ratio [HR] 0.19 [95% CI 0.13–0.28]; P < 0.0001). The overall response rate was 92% in the VEN+R arm compared with 72% for those treated with B+R.

    In patients treated with VEN+R, the most common adverse reactions (incidence ≥20%) were neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough, and nausea. Grade 3 or 4 neutropenia developed in 64% of these patients, and grade 4 neutropenia developed in 31%.

    Serious adverse reactions occurred in 46% of patients. Serious infections developed in 21% of patients, most commonly pneumonia (9%).

    Due to rapid reduction in tumor volume, tumor lysis syndrome (TLS) is an important identified risk with venetoclax treatment. See the prescribing information for TLS risk stratification, prophylaxis, and monitoring.

    All approved venetoclax regimens begin with a 5-week ramp-up. Full prescribing information is available at Venclexta PI.

  • June 5, 2018

    FDA approved pegfilgrastim-jmdb as the first biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection as suggested by febrile neutropenia in patients with nonmyeloid (non–bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

    FDA’s approval of the new biosimilar was based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates pegfilgrastim-jmdb is biosimilar to pegfilgrastim. It has been approved as a biosimilar, not as an interchangeable product.

    The most common adverse effects are bone pain and pain in extremities. Patients with a history of serious allergic reactions to human granulocyte colony–stimulating factors such as pegfilgrastim or filgrastim products should not take the new biosimilar.

    Serious adverse effects from treatment include rupture of the spleen, acute respiratory distress syndrome, serious allergic reactions including anaphylaxis, acute inflammation of the kidney, an abnormally high level of white blood cells, capillary leak syndrome, and the potential for tumor growth. Fatal sickle cell crises also have occurred.

  • June 4, 2018

    Eli Lilly and Incyte announced FDA approval of a 2-mg dose of baricitinib, a once-daily oral medication to treat moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to one or more tumor necrosis factor (TNF)–inhibitor therapies.

    Use of baricitinib in combination with other Janus kinase inhibitors or biologic disease–modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended. Baricitinib may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs.

    Approval was based on a clinical trial program that included the RA-BEACON study, a randomized, double-blind, placebo-controlled study in which patients were randomly assigned to receive baricitinib 2 mg, baricitinib 4 mg or placebo, in addition to conventional DMARDs they were currently using. The study included 527 patients who had an inadequate response or intolerance to one or more TNF-inhibitor therapies. Patients could have had prior therapy with other bDMARDs.

    The study results showed significantly higher ACR20 response rates and improvement in all individual ACR20 component scores at week 12 with use of baricitinib. Patients treated with baricitinib had significantly higher rates of ACR20 response versus patients treated with placebo at week 12 (49% of baricitinib-treated patients versus 27% of placebo-treated patients).

    Baricitinib also demonstrated early symptom relief, with ACR20 responses seen as early as week 1. Patients reported significant improvements in physical function according to the Health Assessment Questionnaire Disability Index (HAQ-DI) (recording an average score of 1.71 before treatment and 1.31 at week 12) compared with placebo-treated patients (who recorded an average score of 1.78 before treatment and 1.59 at week 12).

    Baricitinib is approved with a boxed warning for the risk of serious infections, malignancies, and thrombosis. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving baricitinib

    Lymphoma and other malignancies have been observed in patients treated with baricitinib as well. In addition, thrombosis—including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal—have occurred in some patients.

    Other warnings and precautions include gastrointestinal perforations, laboratory abnormalities (including neutropenia, lymphopenia, anemia, liver enzyme elevations, and lipid elevations), and a warning against use of live vaccines with baricitinib. 

    The most common adverse events in clinical trials included upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.

    As part of the approval, the companies have agreed to conduct a randomized, controlled clinical trial to evaluate the long-term safety of baricitinib in patients with RA.

  • May 31, 2018

    FDA approved pegvaliase-pqpz for adults with the rare and serious genetic disease phenylketonuria (PKU), in which patients are born with an inability to break down the amino acid phenylalanine (Phe). Phe is present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages.

    The drug is a novel enzyme therapy for adult patients with PKU who have uncontrolled blood Phe concentrations on current treatment.

    Safety and efficacy of the new drug were studied in two clinical trials in adult patients with PKU with blood Phe concentrations greater than 600 µmol/L on existing management. Most of the participants were on an unrestricted diet before and during the trials.

    In the first study, a randomized, open-label trial, patients were treated with increasing doses of pegvaliase-pqpz administered as an S.C. injection up to a target dose of either 20 mg/d or 40 mg/d. The second study was an 8-week, placebo-controlled, randomized withdrawal trial of patients who were previously treated with pegvaliase-pqpz. Patients treated with pegvaliase-pqpz achieved statistically significant reductions in blood phenylalanine concentrations from their pretreatment baseline blood Phe concentrations.

    The most common adverse events included injection-site reactions, joint pain, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, pruritus, nausea, dizziness, abdominal pain, throat pain, fatigue, vomiting, cough, and diarrhea. Hypersensitivity reactions occurred in most patients, likely because of formation of antibodies to the product.

    The most serious adverse reaction was anaphylaxis, which occurred most frequently during upward titration of the dose within the first year of treatment. Because of this serious risk, the labeling for pegvaliase-pqpz includes a boxed warning, and the product is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Prescribers must be certified by enrolling in the REMS program and completing training.

    Requirements include the following:

    - Prescribers must prescribe auto-injectable epinephrine with pegvaliase-pqpz.

    - Pharmacies must be certified with the program and must dispense only to patients who are authorized to receive pegvaliase-pqpz.

    - Patients must enroll in the program and be educated about the risk of anaphylaxis by a certified prescriber to ensure they understand the risks and benefits of treatment.

    - Patients must have auto-injectable epinephrine available at all times while taking pegvaliase-pqpz.

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