astrazeneca plc-spons adr (AZN) Key Developments
AstraZeneca PLC Wins Approval from US Food and Drug Administration for the Treatment of Advanced Ovarian Cancer in Patients with Germline BRCA-Mutations
Dec 19 14
AstraZeneca PLC announced that the US Food and Drug Administration (FDA) has approved LYNPARZA(olaparib) capsules. LYNPARZA is the first poly ADP-ribose polymerase (PARP) inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. LYNPARZA has been approved under the FDA's Accelerated Approval program, based on objective response rate and duration of response data. Continued approval for this indication is contingent upon verification of clinical benefit in ongoing confirmatory Phase III trials. The FDA approval is based on efficacy data from a single-arm Phase II study1 of LYNPARZA in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as well as safety data from several other studies, including a placebo-controlled study. The efficacy of LYNPARZA is based on analysis of 137 patients with measurable, germline BRCA mutated-advanced ovarian cancer treated with three or more prior lines of chemotherapy. The trial results demonstrated an overall response rate of 34% (95% CI: 26%, 42%; complete response 2%, partial response 32%). The median duration of response was 7.9 months (95% CI: 5.6, 9.6 months). The most common adverse reactions reported have been generally mild to moderate and have included nausea, vomiting, fatigue and anaemia.
AstraZeneca Announces European Commission Grant of Marketing Authorisation for Lynparza as First-in-Class Treatment for Advanced BRCA-Mutated Ovarian Cancer
Dec 18 14
AstraZeneca announced that the European Commission (EC) has granted Marketing Authorisation for Lynparza (olaparib) capsules (400mg twice daily) as the first therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy. Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. It is the first PARP inhibitor to be approved for patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer. Patients will be identified through a validated diagnostic test. The EC decision is applicable to all 28 EU member states as well as Norway, Iceland and Liechtenstein. The approval of olaparib was based on data from Study 191, a Phase II clinical trial that evaluated its efficacy and safety compared to placebo in platinum-sensitive relapsed high grade serous ovarian cancer patients.
European Commission Grants Marketing Authorisation to AstraZeneca's MOVENTIG
Dec 9 14
AstraZeneca announced that MOVENTIG® (naloxegol) has been granted Marketing Authorisation by the European Commission (EC) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved in the European Union (EU). Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which can result in patients suffering from OIC. The approval of MOVENTIG was based on data from the KODIAC clinical programme, which was comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were both placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week open label, long-term safety study. MOVENTIG is a peripherally-acting mu-opioid receptor antagonist (PAMORA) specifically designed for the treatment of opioid-induced constipation (OIC) in adult patients on prescription opioid pain medicines. In Phase III clinical studies, MOVENTIG was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors in tissues such as the gastrointestinal (GI) tract. The KODIAC clinical programme was comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were identically designed, placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week long-term safety study. MOVENTIG is part of the exclusive worldwide licence agreement announced on September 21, 2009 between AstraZeneca and Nektar Therapeutics. MOVENTIG was developed using Nektar's oral small molecule polymer conjugate technology.
Jury in the US District Court for the District of Massachusetts Returns Verdict in Favour of AstraZeneca
Dec 6 14
AstraZeneca announced that a jury in the US District Court for the District of Massachusetts returned a verdict in favour of AstraZeneca in a Multi-District antitrust case filed by various purchaser groups challenging the previous settlement of Nexium patent litigation with Ranbaxy.
AstraZeneca Confirms Acquisition Trail
Dec 3 14
AstraZeneca PLC (LSE:AZN) has confirmed that the company is on acquisition trail. Pascal Soriot, boss of AstraZeneca, has confided that the company is on the acquisition trail for a deal.