AstraZeneca has presented yet more positive data from the landmark JUPITER study which shows that its cholesterol blockbuster Crestor significantly reduces the risk of cardiovascular events in elderly patients.
The new analysis, unveiled at the European Society of Cardiology meeting in Barcelona, demonstrated that a subset of 5,695 patients aged 70 on Crestor (rosuvastatin) had a 39% reduced risk of major cardiovascular events (myocardial infarction, stroke, arterial revascularisation, hospitalisation for unstable angina, or death from CV causes) compared to those on placebo. Specifically, the data revealed 45% decreases in both heart attack and risk of stroke, and reduced the need for hospitalisation for arterial revascularisation or unstable angina by 49%.
AstraZeneca announced overall results from JUPITER in November 2008, which demonstrated that among the full study population (17,802 patients), those who took Crestor had a 44% lower risk of major cardiovascular events. The patients in the trial had low to normal “bad” LDL cholesterol levels but elevated levels of high-sensitivity C-reactive protein and the Anglo-Swedish drugmaker filed a regulatory submission with the US Food and Drug Administration to include the JUPITER data earlier this year.
Full Brilinta data unveiled
In Barcelona, AstraZeneca also presented full data from the previously-announced 18,642-patient Phase III PLATO trial which showed that experimental oral antiplatelet agent Brilinta (ticagrelor) significantly reduced cardiovascular events in patients with acute coronary syndromes, compared with Sanofi-Aventis/Bristol-Myers Squibb's Plavix (clopidogrel).
After 12 months of treatment, 9.8% of patients on Brilinta experienced cardiovascular events (including death, heart attack or stroke), compared with 11.7% in the Plavix arm. This result was achieved without an increase in major bleeding (11.6% versus 11.2%).
AstraZeneca’s executive vice president of development, Anders Ekblom, said the PLATO data suggest ticagrelor “could be a valuable new option for a broad range of ACS patients”. He confirmed that the firm will file Brilinta in the USA and Europe in the fourth quarter and analysts are predicting that the drug could be a blockbuster by 2014.
Vimovo filed in USA
AstraZeneca also noted that the FDA has accepted a New Drug Application (NDA) by development partner Pozen for Vimovo, a combination of the former’s antiulcerant Nexium and the anti-inflammatory naproxen previously known as PN 400.
The combo under investigation for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing non-steroidal anti-inflammatory drug-associated gastric ulcers. The filing has triggered a $10 million milestone payment from AstraZeneca to Pozen, whose shares jumped 9% on the news.
