FDA approves biosimilar to etanercept
The FDA approved a biosimilar to etanercept (Enbrel) for the treatment of rheumatoid arthritis (RA) and multiple inflammatory diseases. Etanercept-szzs is to be marketed as Erelzi, a tumor necrosis factor blocker that is administered subcutaneously for the following indications:
* Moderate-to-severe RA, as a stand-alone therapy or in combination with methotrexate (MTX)
* Moderate-to-severe polyarticular juvenile idiopathic arthritis in patients age 2 and older
* Active psoriatic arthritis, including use in combination with MTX in patients with psoriatic arthritis who do not respond adequately to MTX alone
* Active ankylosing spondylitis
* Chronic moderate-to-severe plaque psoriasis in adult patients (age 18 and older) who are candidates for systemic therapy or phototherapy.
The FDA's approval of a biosimilar means that it has been demonstrated to be as safe and effective as the reference product. The agency states that patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.
In the case of Erelzi, the FDA's approval was based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrate Erelzi is biosimilar to Enbrel. The approval does not mean Erelzi is interchangeable with Enbrel.
CDC recommends two doses for HPV vaccination if started before age 15
The Advisory Committee on Immunization Practices of the CDC now recommends that only two doses of the human papillomavirus (HPV) vaccine are needed if the immunization series begins before age 15. It is hoped that a two-dose schedule will increase use of the vaccine, which has a lower rate of acceptance compared with other childhood vaccinations.
The new schedule directs the first of two doses of the HPV vaccine to be administered at ages 11 or 12 (although it could be given as early as age 9, which is the same as the previous guidance), and the second dose should be given 6 to 12 months after the first dose to protect against cervical, vaginal, vulvar, anal, and oropharyngeal cancers, precancerous lesions, and genital warts. The new recommendation does not apply to adolescents who begin getting the HPV vaccination after age 15, in which case the series remains a three-injection regimen over a 6-month period. In October 2016, the FDA approved adding a two-dose regimen for the HPV nine-valent vaccine for adolescents ages 9 through 14.
The CDC panel recommended the change based on a review of studies showing that two doses of HPV vaccine in younger adolescents produced an immune response similar to that in young adults who received three doses of the vaccine.
FDA warns of hepatitis B reactivation from direct-acting antivirals
The FDA issued a warning regarding the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medications for hepatitis C virus (HCV). The agency has received reports of cases of HBV reactivation in patients treated with DAA medications resulting in serious liver problems (including cirrhosis or liver cancer) or death.
The FDA identified 24 cases of HBV reactivation from reports to the agency and in the published literature in HCV/HBV coinfected patients treated with DAAs during the 31 months from November 22, 2013, to July 18, 2016. This number includes only cases submitted to the FDA, so there are likely additional cases about which the agency is not aware. Of the cases reported, two patients died and one needed a liver transplant.
The FDA is requiring the addition of a boxed warning regarding the risk of HBV reactivation to the drug labels of these DAAs and is directing healthcare professionals to screen and monitor for HBV in all patients receiving DAA treatment. The warning will also be included in the patient information leaflet or medication guides for these medications.