Lantheus Announces the Approval of Perflutren Lipid Microsphere by China’s NMPA

Lantheus Holdings, Inc. recently announced the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the Import Drug License (IDL) for Perflutren Lipid Microsphere Injectable Suspension (marketed as DEFINITY in the US), the company’s diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms. The company’s partner, China Resources Double-Crane Pharmaceutical Co., Ltd (CR Double-Crane), will be responsible for commercializing DEFINITY in China under a local brand name. Under the distribution agreement, Lantheus will supply DEFINITY to CR Double-Crane for a launch in China.

With this approval, DEFINITY is indicated in China for use in patients with suboptimal conventional echocardiography and to better identify the left ventricular endocardial border.

“We congratulate our partner, CR Double-Crane, on the successful approval of DEFINITY in China, which further expands our global presence,” said Mary Anne Heino, President and CEO, Lantheus. “Heart disease has been on the rise in China over the last decade and an estimated one in five adults there has cardiovascular disease. This public health emergency has created a significant need for high quality imaging agents like DEFINITY. We are excited to join with CR Double-Crane to improve patient outcomes in China.”

Lantheus entered into a development and distribution arrangement with CR Double-Crane for the commercialization of DEFINITY in China, Hong Kong and Macau. As part of the agreement with Lantheus, CR Double-Crane conducted confirmatory clinical trials with DEFINITY on Lantheus’ behalf in pursuit of cardiac, liver and kidney imaging indications, as well as a pharmacokinetic study.

The efficacy of DEFINITY administration during echocardiography was assessed in a prospective independent blinded evaluation of non-contrast and DEFINITY contrast images for left ventricular endocardial border delineation (i.e., assessment of left ventricular endocardial segments) and left ventricular opacification in more than 600 subjects. These subjects came from clinical trials that enrolled similar patient populations with suboptimal echocardiography images, study designs and imaging procedures. The confirmatory study conducted in China in 120 subjects (DEFINITY 311) confirmed the findings reported for the North American population.

The safety data included several clinical trials that evaluated the use of activated DEFINITY in 1,716 patients (1063; 61.9% were male and 653; 38.1% were female) with a mean age of 56.1 (range 18 to 93). Of these, 144 (8.4%) patients had at least one treatment-related adverse reaction. Among the 1,716 DEFINITY patients studied, serious adverse events were reported in 30 patients. None of the serious adverse events were considered related to DEFINITY administration. Adverse events appeared within minutes (1 – 15 min) of the drug administration and were of moderate intensity, resolving usually without treatment within minutes or hours after onset. Sub-analyses by age, gender and race were performed. The overall incidence of adverse events was similar for the <65-year age group and the ≥65-year age group, similar in males and in females, and similar among all racial or ethnic groups. The most frequent adverse events were reported for the central and peripheral nervous system (3.1%), body as a whole (2.4%) and gastrointestinal system (1.8%). The most frequently occurring treatment-related adverse experiences were headache (2.3%), back/renal pain (1.2%), flushing (1.1%) and nausea (1.0%).

DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension (activated) is approved in the U.S. as an ultrasound enhancing agent for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com). DEFINITY is engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle. DEFINITY has extensive safety experience and a consistent safety profile. Since its launch in 2001, more than 21 million echo studies have been performed with DEFINITY, and it is the most prescribed ultrasound enhancing agent in the US.

DEFINITY is not approved in the US for stress echocardiography.

In post-marketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [see Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.

With more than 60 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Lantheus is headquartered in Massachusetts and has offices in New Jersey, Canada, and Sweden. For more information, visit www.lantheus.com.