AstraZeneca, GSK, Bayer Lead Drug Approval News
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from AstraZeneca, GlaxoSmithKline, and Bayer.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, October 18, 2017 to Tuesday, October 31, 2017.
FDA OKs New Lymphoma Drug by AstraZeneca
The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Calquence (acalabrutinib) for treating adults with mantle cell lymphoma who have received at least one prior therapy.
Calquence is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread, according to information from the FDA.
Calquence was approved using the accelerated approval pathway under which the FDA may approve drugs for serious conditions where there is unmet medical need and when the drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients.
FDA OKs GSK’s Shingles Vaccine Shingrix
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) Shingrix (zoster vaccine recombinant, adjuvanted) for preventing shingles (herpes zoster) in adults aged 50 years and older.
Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for using Shingrix at its meeting in October 2017.
Following this approval from FDA and pending a recommendation from ACIP, Shingrix will be available shortly. In October 2017, Shingrix was approved in Canada for preventing shingles (herpes zoster) in people aged 50 years or older. Regulatory filings in the European Union, Australia, and Japan are underway.
Bayer Gets FDA OK for New Dose of Thrombosis Drug Xarelto
The US Food and Drug Administration (FDA) has approved a label update for Bayer’s Xarelto (rivaroxaban), an oral Factor Xa inhibitor, to include a 10-mg once-daily dose for the extended treatment of recurrent venous thromboembolism.
This label update applies to patients at a continued risk of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) who have already received at least six months of standard anticoagulation therapy. The European Commission approved an update to the label for Xarelto in the European Union in October 2017.
Xarelto is approved for seven indications: (1) the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and one or more risk factors; (2) treating PE in adults; (3) treating DVT in adults; (4) preventing recurrent PE and DVT in adults; (5) preventing venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery; (6) preventing VTE in adult patients undergoing elective knee replacement surgery; and (7) preventing atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an acute coronary syndrome in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine.
Rivaroxaban was discovered by Bayer and is being jointly developed with Janssen Research & Development, part of the pharmaceutical companies of Johnson & Johnson. Xarelto is marketed outside the US by Bayer and in the US by Janssen Pharmaceuticals.
FDA OKs New Formulation for AstraZeneca’s Diabetes Drug Bydureon
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in a once-weekly, single-dose autoinjector device for improving glycemic control in adults with Type 2 diabetes. The drug is approved for adults with Type 2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise.
Bydureon BCise has a continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state, according to information from AstraZeneca.
Bydureon BCise will be available for patients in the US in the first quarter of 2018. A regulatory application for the new autoinjector device has also been accepted by the European Medicines Agency.