por Olga Deshchenko
, DOTmed News Reporter | June 27, 2011
From the June 2011 issue of HealthCare Business News magazine
One PET drug producer got a jumpstart on the requirements. In early February, PETNET Solutions, Inc., a wholly owned subsidiary of Siemens Medical Solutions USA Inc., became the first commercial entity to file an application and receive FDA approval for a PET agent as mandated by FDAMA.
PETNET received FDA approval for its ANDA for Fludeoxyglucose F 18 injection, or FDG, a popular oncology agent. The company submitted the application more than three years ago, says Edward Plut, vice president, product management and marketing, with PETNET. “To date, we’re the only commercial manufacturer to even submit an application, let alone to be approved by the FDA,” he says.
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More than a decade seems like a long time for establishing the regulations, but in many aspects, PET drugs were uncharted territory for the FDA. “Throughout these proceedings, we’ve tried to be sensitive to the fact that we are bringing under regulatory control an industry that had been largely unregulated and an industry with special characteristics,” Axelrad said at the meeting.
With more clarity from the FDA, industry experts hope to see novel PET agents glide through the regulatory process in the near future and pave the way for PET radiopharmaceuticals currently in development.
PET meets CAD
Lantheus Medical Imaging Inc., a North Billerica, Mass.-based diagnostic imaging company, is hoping to add a new PET cardiac imaging agent to the list of approved drugs. Lantheus is developing Flurpiridaz F 18, a myocardial perfusion agent for imaging of patients with coronary artery disease.
In early March, the company reached an agreement with the FDA on a Special Protocol Assessment on the design and planned analysis of the Phase 3 clinical trial for the drug.
“This is a significant milestone for Lantheus because it provides a very clear path towards the final approval of the agent and it gives us great clarity on what exactly we need to do to get there,” says Dr. Dana Washburn, the company’s vice president, clinical development and medical affairs. “From a development perspective, it lowers the overall risk to the program because we know exactly what we need to do as we proceed into Phase 3.”
Currently, SPECT is the dominant modality for noninvasive detection of CAD but the approval of Flurpiridaz can turn PET into a worthy competitor.
According to Washburn, PET has higher image quality than SPECT and offers certain technical features such as reduced attenuation and more robust attenuation correction, which reduces artifacts often prevalent in other modalities. PET also holds a lot of potential for novel applications, such as the ability to measure absolute quantitative blood flow in the heart. “I think the hope is that all of these characteristics lead to better diagnostics decisions and therefore better outcomes for patients,” says Washburn.