A radioactive compound that lights up plaques in the brain to help diagnose Alzheimer's disease has been approved by the Food and Drug Administration for use in patients being evaluated for Alzheimer's and other causes of cognitive decline.
The imaging agent, Amyvid, was developed by a Philadelphia biotech start-up, Avid Radiopharmaceuticals Inc., now owned by Eli Lilly & Co. It can show amyloid deposits in the brain that are visible on positron-emission tomography (PET) scans. The product got the green light late Friday and will be available in June.
Spun out of research at the University of Pennsylvania, Avid was bought in November 2010 by Eli Lilly for an initial $300 million. The deal called for an additional $500 million if certain commercial and regulatory milestones were reached, including FDA approval of the chemical known as florbetapir F 18 injection.
The dye binds with plaques that are a marker of Alzheimer's disease and that have been studied in several thousand people and in three clinical studies.
"We're excited. The approval means that this product will finally be available to the patients who need, and can benefit from, this," said Avid Radiopharmaceuticals' founder and chief executive officer, Daniel Skovronsky, 39, a Penn neuropathologist.
"The type of patient who will benefit from this test are people who have symptoms of cognitive decline, such as memory loss," he said. "A physician can order the scan, and it will give them information about the presence, or absence, of amyloid plaques in the brain."
Amyloid plaques are a "hallmark pathology" of Alzheimer's disease, but the diagnosis is "sometimes given inappropriately," Skovronsky said. "Out of all the patients who get a diagnosis of Alzheimer's, one out of five turn out not to have it. They had something else," such as vascular disease, stroke, Parkinson's disease, or "something as common as depression that can cause cognitive decline in the elderly."
Amyvid could help doctors rule out Alzheimer's in some patients with memory problems.
Avid's 75 employees at 3711 Market St. in University City are working with a team at Eli Lilly in Indianapolis on the commercial launch, sales, and marketing.
"It's our desire to make this widely available in the United States, beginning in June," Skovronsky said. "It will be up to individual physicians and their imaging center to decide whether they want to offer it."
Experts say as many as 5.4 million Americans of all ages have Alzheimer's, a memory-robbing disease.
Before granting approval, the FDA urged Avid to develop training for physicians so that there would be uniformity in reading the scans and that doctors could agree about what they see. The company has devised online training videos and in-person lectures.
R. Edward Coleman, a consultant to Eli Lilly and professor of radiology at Duke University Medical Center, said, "This approval marks a great advancement in nuclear medicine practice."
Amyloid can be present without symptoms of dementia. "That's why we say this is not a stand-alone diagnostic; this is just one test that is an adjunct in helping physicians come up with the diagnosis," Skovronsky said.
Avid's technology was developed after a decade of work by Hank Kung, a Penn chemist, who worked with Skovronsky. Kung remains a consultant and adviser.
Pharmaceutical companies are testing several new Alzheimer's drugs aimed at reducing amyloid-plaque buildup in the brain.
"In the clinical trials that are testing those drugs, they are also using our compound in an investigational manner to see if they can identify the right patients to treat and monitor their response to therapy," Skovronsky said.
Avid raised $70 million before Eli Lilly bought the company. Earlier investors included Safeguard Scientifics Inc. of Wayne, Alta Partners, AllianceBernstein Venture Fund, Pfizer Strategic Investments Group, RK Ventures, and BioAdvance.
The company also is working on diagnostic imaging agents for Parkinson's, diabetes, and other neurodegenerative diseases.