Kolon’s Invossa-K Phase 3 clinical trial to continue after FDA nod
Category: #health  By Saipriya Iyer  Date: 2020-04-13
  • share
  • Twitter
  • Facebook
  • LinkedIn

Kolon’s Invossa-K Phase 3 clinical trial to continue after FDA nod

Kolon Life Science has announced that it has received an approval to continue Invossa-K’s phase-3 clinical trial by the U.S. Food and Drug Administration. Invossa-K is a gene therapy for osteoarthritis and the trial is being run in the United States. 

Apparently, the FDA gave its approval for the drug test nearly a year after it had suspended the study. The Korean regulator had revoked the Invossa license on account of an ingredient mislabeling. The latest decision made by the FDA has given Kolon a fresh start concerning the Invossa business.

The FDA had sent an official notice to a Kolon Life Science subsidiary, Kolon TissueGene, that it will be removing the clinical hold on the Invossa’s phase 3 trial. As per the Kolon TissueGene, the FDA stated that the issues regarding the clinical hold had been resolved and the firm will be able to continue with the Invossa clinical trial.

Kolon had initiated Invossa’s phase-3 study on October 30 in 2018 in the U.S., which was later suspended by the FDA in 2019. The firm had admitted that the cell ingredient that came from the second fluid of the drug had not been derived from the cartilage but the kidney, which is also called GP2-293. The company had submitted the extra data twice for clearance from the regulatory body.

According to sources familiar with the matter, the FDA had requested the firm to submit supplementary materials that also include the ingredients of Invossa like the evaluation of the cell’s identity covering the way the drug composition has changed and the forthcoming measures. The regulator had demanded for analysis of the properties of Invossa ingredients.

The FDA has asked the firm to submit data placed on the stability of all the clinical samples as well as the improvement measures for the production process of Invossa.

 

Source credit- http://www.koreabiomed.com/news/articleView.html?idxno=7986



About Author

Saipriya Iyer

Email: [email protected]   

Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

Read More

More News By Saipriya Iyer

Montero inks agreement to acquire Isabella Gold Silver Project
Montero inks agreement to acquire Isabella Gold Silver Project
By Saipriya Iyer

Montero Mining and Exploration Ltd. has reportedly inked a Binding Purchase & Sale Agreement to acquire a 100% or full interest in a private company in Chile. ChileCo holds several mineral rights to exploration cla...

PharmaCyte to submit IND application to FDA for clinical trial in LAPC
PharmaCyte to submit IND application to FDA for clinical trial in LAPC
By Saipriya Iyer

PharmaCyte Biotech, a clinical-stage biotechnology company, is reportedly set to submit an IND (Investigational New Drug) application to the U.S. FDA. The IND application is related to the Phase 2b clinical trial among...

Immunic announces topline data from Phase 2 EMPhASIS, IMU-838 trial
Immunic announces topline data from Phase 2 EMPhASIS, IMU-838 trial
By Saipriya Iyer

Immunic, Inc. has recently announced positive topline results from the Phase 2 EMPhASIS trial of IMU-838, in patients with RRMS (relapsing-remitting multiple sclerosis). IMU-838 is a next-generation, orally available s...