Inside INdiana Business

Lilly receives three FDA approvals

(Photo Provided/Eli Lilly and Co.)

INDIANAPOLIS (Inside INdiana Business) – The U.S. Food and Drug Administration has awarded three new approvals to Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The pharmaceutical company says the approvals will benefit patients with Alzheimer’s disease and lung cancer, among others.

Lilly received approval for TAUVID, which is used for patients being evaluated for Alzheimer’s. TAUVID is a radioactive diagnostic agent used to conduct positron emission tomography, or PET, imaging of the brain.

Lilly says its subsidiary, Avid Radiopharmaceuticals Inc., developed TAUVID and AMYVID to provide physicians with meaningful information on the presence of both pathologies to aid the evaluation of patients suspected of having AD.

“The fight against AD requires precise and reliable assessments of the two key pathologies of the disease because clinical assessments alone are limited in their ability to accurately diagnose patients,” said Dr. Mark Mintun, vice president of Lilly’s pain and neurodegeneration research and development. “History was made with the FDA approval of AMYVID to demonstrate the presence of one of those two pathologies, beta-amyloid plaques. I am excited that TAUVID has now been approved to image tau NFTs, which is the other key pathology, allowing a more comprehensive evaluation of patients.”

Lilly’s CYRAMZA was approved as a first-line treatment for metastatic EGFR-mutated non-small cell lung cancer. With the approval, CYRAMZA has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers.

The company says its drug Taltz is the first of its kind to receive FDA approval for the Treatment of Non-Radiographic Axial Spondyloarthritis. Lilly says the disease predominantly affects the sacroiliac joints and the spine, resulting in chronic inflammatory back pain and fatigue.

“We recognize that many patients living with this condition suffer from chronic inflammatory back pain and other symptoms of inflammation for years before being diagnosed, and we’re excited about the possibility of these patients finding relief with Taltz,” said Patrik Jonsson, senior vice president and president of Lilly Bio-Medicines.

Lilly says the approval reaffirms the track record that Taltz has in providing efficacy for patients. With this approval, Taltz has now received five FDA approvals. Taltz was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque psoriasis.