FDA Approvals Roundup: Adlarity and Lynparza
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).New approvals
Adlarity transdermal patch okayed for dementia in patients with Alzheimer’s disease
Corium’s Adlarity (donepezil; transdermal system) has been approved for mild, moderate, or severe dementia in patients with Alzheimer's disease. The drug was approved via the 505(b)(2) pathway that allows drugs to be approved based in part on data from studies conducted by other parties.
The once-weekly patch delivers consistent and continual doses of donepezil through the skin through the company’s Corplex transdermal technology, bypassing the digestive system and reducing the possibility of gastro-intestinal side effects.
Approval of Adlarity was based on findings from a relative bioavailability study in which patients were treated with Adlarity or Aricept (donepezil hydrochloride tablets).
New indications
Lynparza nabs expanded use for high-risk, early-stage, mutated breast cancer
AstraZeneca’s Lynparza (olaparib; tablets) has been granted a new indication as an adjuvant therapy for high-risk, early-stage, HER2-negative, germline BRCA-mutated breast cancer in patients who have received neoadjuvant or adjuvant chemotherapy.
Myriad Genetic’s BRACAnalysis CDx was approved as a companion diagnostic test for identifying patients who might benefit from Lynparza.
Approval of Lynparza was based on findings from the double-blind, placebo-controlled, OlympiA study in which 1,836 patients from the indicated population were randomized 1:1 to receive Lynparza or placebo. The findings showed a statistically significant improvement in invasive disease-free survival (IDFS) and overall survival (OS) in patients in the Lynparza arm compared with those in the placebo arm. IDFS at 3 years was 86% for patients receiving Lynparza and 77% for the placebo patients. In all, there were 75 deaths (8%) in the Lynparza arm and 109 (12%) in the placebo arm.
The application was granted priority review. The review used the assessment aid and was conducted under Project Orbis in collaboration with Health Canada and Swissmedic.
Lynparza, a PARP inhibitor, was originally approved in 2017 for maintenance and treatment of ovarian cancer and is also used in treating pancreatic, prostate, and breast cancers.
