All The Most Important Pharmaceutical News Stories Of The Week – January 2018 – Week #5
Amgen Reports Aimovig™ (Erenumab) Met All Primary and Secondary Endpoints in Unique Phase 3b Study in Episodic Migraine Patients Who Have Failed Multiple Prior Preventive Treatments
January 22, 2018
Amgen has announced positive results from the Phase 3b LIBERTY study assessing the efficacy and safety of Aimovig™ (erenumab) 140 mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures, due to lack of efficacy or intolerable side effects. The study met its primary endpoint, with significantly more patients taking Aimovig experiencing at least a 50 percent reduction from baseline in their monthly migraine days as compared to placebo. LIBERTY also met all secondary endpoints, including reduction of monthly migraine days, reduction in days needing acute (rescue) medication, improvement in scores on the Migraine Physical Function Impact Diary (MPFID) tool, and 75 percent and 100 percent responder rates (number of patients experiencing at least a 75 percent or 100 percent reduction in monthly migraine days compared to placebo). The safety data are consistent with previous studies of Aimovig to date. Full data will be presented at an upcoming scientific meeting.
Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Receives European Commission Approval for CD30-Positive Cutaneous T-Cell Lymphoma after at Least One Prior Systemic Therapy
January 22, 2018
Seattle Genetics, Inc. has reported that its collaborator, Takeda Pharmaceutical, announced that the European Commission has extended the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non-Hodgkin lymphoma, including CTCL. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on November 9, 2017.
January 24, 2018
Pfizer Inc. has announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera® (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan® (rituximab-US)/MabThera®. The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma.
Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors
January 26, 2018
Novartis AG has announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera® (lutetium Lu 177 dotatate) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults. Lutathera, which received orphan drug designation from the FDA, is a first-in-class drug and the first available FDA-approved Peptide Receptor Radionuclide Therapy (PRRT), a form of treatment comprising of a targeting molecule that carries a radioactive component. The approval was based on a Phase 3 study which demonstrated a 79% reduction in the risk of disease progression or death within the Lutathera plus best standard of care arm (octreotide LAR 30mg every four weeks) compared to 60 mg of octreotide LAR alone (hazard ratio 0.21, 95% CI; 0.13-0.32; p<00.001). Novartis recently completed a successful tender offer for Advanced Accelerator Applications to become a subsidiary within the Novartis Group.
January 26, 2018
Roche has announced that the EU CHMP has adopted a positive opinion for Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors. The CHMP has recommended Hemlibra for use in all age groups. Nearly one in three people with severe haemophilia A can develop inhibitors to factor VIII replacement therapies, putting them at greater risk of life-threatening bleeds or repeated bleeding episodes that can cause long-term joint damage. The Hemlibra Marketing Authorisation Application is being reviewed under accelerated assessment, a procedure granted to medicines that the CHMP believes are of major interest for public health and therapeutic innovation. Based on the positive CHMP recommendation, a final decision regarding the approval of Hemlibra is expected from the European Commission in the near future.
AstraZeneca reports top-line Phase III KRONOS trial results for PT010 triple combination therapy in chronic obstructive pulmonary disease
26 January 2018
AstraZeneca has announced top-line results from the Phase III KRONOS trial that showed PT010 (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6µg, using Aerosphere Delivery Technology, in a pressurized metered-dose inhaler or pMDI) demonstrated a statistically significant improvement compared with dual combination therapies in six out of seven lung function primary endpoints based on forced expiratory volume in one second (FEV1) assessments in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). In total, eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators.
January 26, 2018
Takeda announced the signing of a framework agreement whereby its wholly-owned subsidiary, Takeda Pharmaceuticals International AG, has the option to acquire a range of over-the-counter (OTC) medicines and food supplements from Unipharm Inc. (Unipharm), a specialist healthcare company headquartered in New York, U.S.A. These products are for promotion and sale primarily in Russia, where Takeda has a strong presence providing innovative medicines, primary care medicines and OTC products to its people and patients. The portfolio is a strong strategic fit with Takeda’s Russian OTC business.
January 26, 2018
GlaxoSmithKline plc and Innoviva, Inc. have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS) / long-acting ?2-agonist (LABA) combination, in patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting ?2-agonist.Top Pharma News of the Weeklast edit: 2018-01-30T16:31:17+00:00da