Sample Record

Sample Record for Search: Drug Approvals

Drug: technetium (99mTc) tetrofosmin; tetrofosmin
Brand: MYOVIEW

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Originator:: Nycomed Amersham; (UK); licensor

Licensee/Licensor:: Mallinckrodt; (USA); International Minerals & Chemicals; licensee; USA

Patent Assignee:: Amersham

CAS® Registry Number:: 127455-27-0; technetium (99m Tc) tetrofosmin; 127502-06-1; tetrofosmin

Laboratory Code:: P 53; PPN 1011

Pharmacological Action:: contrast medium; radiodiagnostic

Therapeutic Class:: Other Imaging Agents

Clinical Indications:: diagnosis

Chemical Name:: (OC-6-11)-bis[6,9-bis(2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetrad ecane-P,P']d ioxotechnetium(1+)-99Tc

Latest Information:
17 March 2003: The US FDA has approved Amersham's cardiac imaging agent, technetium (99m Tc) tetrofosmin (MYOVIEW), for the assessment of left ventricular function in patients being evaluated for heart disease.

The agent received FDA approval in 2001 for use with pharmacologic stress agents in patients with known or suspected coronary artery disease who are physically unable to exercise. European approval of the product as a breast tumor imaging agent was granted in 2002.

MYOVIEW has been launched in Japan, Europe and the USA, as well as other markets, as a radiopharmaceutical for cardiac perfusion imaging.

Highest Phase of Current Development:: Marketed

Development Phase/Country/Indication:: Marketed, Japan; Marketed, Europe; Marketed, USA

Development History:

MAR 2003: Registered, USA (for assessment of left ventricular function).

NOV 2001: Registered, USA (for use with pharmacologic stress agents).

FEB 2000: Approvable, USA (for use with pharmacologic stress agents).

OCT 1997: Amersham merged with Nycomed.

MAY 1997: Licensed to Mallinckrodt.

JAN 1997: Conjugate launched in Japan.

APR 1996: Marketed, USA.

FEB 1996: Registered, USA.

JUL 1995: Approvable, USA.

MAY 1994: Marketed, Europe.

APR 1994: Marketed, Japan.

JAN 1994: Registered, Japan.

OCT 1993: Recommended, Europe. Pre-registration, USA, Japan.

DEC 1991: Phase III, UK.

1988: Priority product patent application filed, UK.

Commercial Summary:
Nycomed Amersham's cardiac imaging agent technetium (99m Tc) tetrofosmin was launched in Japan April 1994, in Europe May 1994, and in the USA April 1996 for the evaluation of heart disease by myocardial scintigraphy and of myocardial function by first-pass technique. 99m Tc tetrofosmin was approved in the USA February 1996 and was launched through its collaborator Nihon Medi-Physics. Mallinckrodt will co-market this agent in the USA (Reuters, MAY 1997). The product has also been approved by the US FDA for its use with pharmacologic stress agents, which are used in the diagnosis of coronary artery disease in patients unable to exercise (Nycomed Amersham, NOV 2001). The FDA has also approved the product for the assessment of left ventricular function in patients being evaluated for heart disease (Nycomed Amersham, MAR 2003). The agent received European approval for breast tumor imaging in 2002. (Amersham reviewed, AUG 1997)

Scientific Summary:
In anesthetized pigs following partial or complete occlusion of the left anterior descending (LAD) coronary artery, there was an approximately linear relationship between myocardial uptake of technetium (99m Tc) tetrofosmin and myocardial blood flow. In humans, sensitivity of 99m Tc tetrofosmin for detection of greater than 90% of coronary artery stenoses was 84% and specificity was 93%.

Patent Summary:
Product: EP 337654 A 1989, priority GB 8414 1988, designating 12 states. Equivalents identified in seven countries.

Source: R&D Focus, March 17, 2003

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