We are excited to achieve this milestone to determine a regulatory pathway for first of its kind digital pharmaceutical product- Fulvestrant Cancer Treatment Platform (FCTP™)
Houston, TX (PRWEB)
September 16, 2017
Witty Health Inc., a technology company focused on technology enabled cancer drug development, today announced submission of pre-Request For Designation (RFD) documents for its software-enabled Fulvestrant product for treating certain types of breast cancer to the Office of Combination Products (OCP), Food And Drug Administration. A Request For Designation (RFD) filing helps the OCP to identify and assign reviewing responsibility for the drug within the FDA.
“We are excited to achieve this milestone to determine a regulatory pathway for first of its kind digital pharmaceutical product- Fulvestrant Cancer Treatment Platform (FCTP™),” said Co-Founder Ram Sesha. “Witty Health’s Cancer Treatment Platform (CTP™) is designed to develop value-based cancer pharmaceutical products. We are applying software and machine learning tools to oncology products to improve cancer care. This will enable Witty Health to actively customize its Cancer Treatment Platform (CTP™) to other oncology drugs to improve cancer care. To seek a Fast Track designation, the development is in frequent collaboration with the Food and Drug Administration (FDA).”
“The current cancer treatment model does not monitor a patient’s condition between office visits and it is not working. Fulvestrant Cancer Treatment Platform (FCTP™) is designed to improve outcomes associated with Fulvestrant. This is more so when Fulvestrant is used in combination with CDK 4/6 inhibitors Ibrance®, Abemaciclib, and Kisqali®. Further, we believe our product can significantly reduce preventable health care costs by reducing ER visits and hospitalizations due to symptom exacerbations as well,” said Dr. Karthik Koduru, the Chief Oncologist of Witty Health.
Fulvestrant (marketed under brand name Faslodex® by AstraZeneca) is an Estrogen Receptor Modulator. Fulvestrant is approved for the treatment of metastatic breast cancer intolerant to anti-estrogen therapy and in combination with Pfizer’s palbociclib (Ibrance) for the advanced breast cancer intolerant to endocrine therapy. Fulvestrant,…