The drug regulator said it has granted S.Biomedics to extend the submission of phase-3 clinical data for CureSkin Inj., autologous cell therapy for acne scars that had won conditional approval.
According to the minutes released by the Ministry of Food and Drug Safety’s central pharmaceutical affairs advisory committee on Friday, the government allowed the extension of data submission.
The company obtained the nod for CureSkin Inj. in 2010, on the condition that it submits phase-3 data to the regulator. After releasing the product in 2016, the company reduced the number of participants in post-marketing surveillance to 100 from over 600.
The minutes of the Central Pharmaceutical Affairs Advisory Committee earlier this year showed that the company failed to confirm the drug’s efficacy in the phase-3 study.
However, S.Biomedics said it would conduct a new clinical test to prove the drug’s effectiveness and requested an extension of phase-3 data submission.
“Considering that the drug is an autologous cell therapy and its safety information, there seems no problem in safety issue. However, we need to consider the objectivity of the primary endpoint of the additional clinical trial,” said one of the committee members.
Another panelist said, “I agree on the validity of the extension of data submission. If we discontinue the supply of acne scar treatment, patients could face a problem in choosing a treatment option.”
Other members opined that additional trials could be permitted if the regulator clearly states about the criteria for “validation,” which is one of the reasons for the failure of confirming efficacy. Validation refers to verifying and documenting specific processes, methods, equipment, and systems to derive results that meet predetermined criteria.
The panelists decided to allow an additional trial, on the condition that the company can conduct the right validation.
“We had an opinion that if we give another chance to conduct a new trial due to the credibility of the past test, it would be difficult to trust the result of the new trial,” the committee head said. “After the comprehensive review of the committee embers’ opinions, however, we concluded that an extension of phase-3 data submission for conditional approval was appropriate,”
However, the committee recommends that a new trial should be supplemented with detailed plans such as blind method, education for evaluating the endpoint, validation, and calculating a sufficient number of participants to verify a hypothesis, he added.
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