FDA approves Brilinta 60 mg tablets
WILMINGTON, Del. — AstraZeneca on Thursday announced that the Food and Drug Administration approved Brilinta (ticagrelor) tablets at a 60 mg dose for patients with a history of heart attack beyond the first year.
Brilinta is intended to reduce the rate of cardiovascular death, heart attack and stroke in patients with acute coronary syndrome.
"We know that patients remain at risk beyond the first year after their heart attack," said Elisabeth Björk, VP and head of Cardiovascular and Metabolic Diseases for AstraZeneca’s global medicines development division. "Today's approval provides an important new treatment option and underscores the role Brilinta can play in reducing the risk of a subsequent cardiovascular event for patients both in the acute setting and in the longer term."
First approved by the FDA in 2011, the oral antiplatelet treatment inhibits platelet activation and reduces the rate of stent thrombosis, according to AstraZeneca.
The recommended maintenance dose of Brilinta is 90 mg twice daily for the first year after an ACS event. It should be used with a daily maintenance dose of aspirin of 75-100 mg.
Ancino launches generic Exelon patch
AESCH, Switzerland — Ancino this week launched its rivastigmine patch, a generic version of the Exelon patch. The transdermal treatment is intended for mild to moderate dementia associated with Alzheimer’s disease, and is available in 4.6-mg 24-hour strength, 9.5-mg 24-hour strength and 13.3-mg 24-hour strength.
Acino’s rivastigmine patch will be marketed by Alvogen. This is the first of a series of products Acino plans to launch in the U.S., building on its patch business in Europe
Pfizer completes Hospira acquisition
NEW YORK — Pfizer this week announced that it had completed its acquisition of injectable and infusion drug maker Hospira. Pfizer said that the transaction has strengthened the company’s branded and generics portfolio, particularly when it comes to biosimilars, the market for which is expected to hit $20 billion in 2020, and the first of which was launched in the U.S. on Thursday.
“Together, we are … a leading global biosimilars company with a robust pipeline, best-in-class development capabilities and extensive real-world commercialization experience,” John Young, group president global established pharmaceutical business, said. “By increasing the number and availability of high-quality generic injectable drugs and biosimilars that we offer our customers, we are strengthening our commitment to improving the health and quality of life of patients around the world with high quality medicines across key therapeutic areas.”
The company expects the transaction to boost earnings per share by about $0.10 to $0.12 per share in the year after closing, and will adjust its 2015 guidance to incorporate Hospira in the coming weeks.