AstraZeneca and MSD‘s Olaparib has been approved by the European Commission for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer. The approval allows for the first PARP inhibitor approved in Europe for patients with this difficult-to-treat disease, and the third EU approval for Olaparib. The European commission made the approval based on data from
AstraZeneca has received approval from the European Commission for the use of Dapagliflozin as an adjunct to insulin to treat type-1 diabetes. The indication covers adult patients with a BMI of 27 or more who often cannot achieve adequate glycaemic control with insulin alone, despite optimal therapy. Dapagliflozin is said to be the first AstraZeneca drug
AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision enables doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The
AZ’s Tagrisso has been given a go-ahead in Europe for first-line use to treat EGFR-mutated non-small cell lung cancer (NSCLC), offering a new line of attack at this stage of the disease. The decision was based on clinical data from the Phase III FLAURA trial, showing that progression free survival in patients taking Tagrisso (osimertinib)
In final guidance, NICE backs usage of AstraZeneca’s drug as long-term treatment for patients who have suffered a heart attack and are at high risk of a further cardiovascular event. The UK agency’s final guidance recommends the anti-clotting therapy for NHS use at a lower dosage than was previously available, backing AZ’s treatment as a
The European Commission has approved AstraZeneca’s Qtern, a two-drug therapy for type 2 diabetes that was turned down in the US last year. The diabetes therapy combines active ingredients in AZ’s DPP-4 inhibitor Onglyza (saxagliptin) with SGLT2 inhibitor Farxiga/Forixiga (saxagliptin), making it the second drug of its type on the market after Eli Lilly and
AstraZeneca’s biologics research and development subsidiary, MedImmune has been granted Orphan Drug Designation by the FDA for its investigational anti-CD19 monoclonal antibody, MEDI-551, for treatment of patients with neuromyelitis optica (NMO) and also neuromyelitis optica spectrum disorders (NMOSD).
Roche and AstraZeneca have received US FDA breakthrough therapy designations for treatments in multiple sclerosis (MS) and bladder cancer, respectively. Roche’s Ocrevus (ocrelizumab) has become the first investigational medicine to receive the designation for MS. Specifically, the drug treats primary progressive multiple sclerosis (PPMS), a debilitating form of the disease characterised by steadily worsening symptoms
Three months after US regulators gave the treatment the green light, AstraZeneca’s new lung cancer pill, Tagrisso, has won early approval for use in the EU. Tagrisso, also known by its clinical name osimertinib AZD9291, is one of six cancer medicines that AstraZeneca hopes will rebuild its sales after losing patent on older drugs.
At a meeting last week, the Committee for Medicinal Products for Human Use (CHMP) backed non-new drugs for approval, which included two drugs from AstraZeneca.