M/s. Hetero Labs Ltd.

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Conrad Townsend
5 years ago
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1 :- The 1 st SEC (Gastroenterology&Hepatology) meeting deliberated the proposals on and recommended the following:- Agenda New Drugs Division Proposal /16-DC Sofosbuvir and Velpatasvir ( mg) tablets Local clinical trial waiver M/s. Hetero Labs Ltd. The firm has applied for the grant of permission to manufacture and market Sofosbuvir (400mg) + Velpatasvir (100mg) Tablets for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infections without cirrhosis or compensated cirrhosis and with decompensated cirrhosis for use in combination with ribavirin and requested for waiver of local clinical trial. The Committee deliberated in details the justification of local clinical trial waiver presented by the firm and opined as follows: 1. There is no unmet medical need, as such for various genotype of hepatitis C drug after approval of Sofosbuvir, Ledipasvir and Daclatasvir as single or combination drugs by considering a local clinical trial waiver for these drugs. 2. Present combination proposed to give the benefits as following: I. It is Pangenotypic for HCV infection II. In combination with Ribaverine has shown high response rates in decompensated liver disease patients infected with Hepatitis C Virus and III. Can be used as single therapy for treatment of Page 1 of 6

2 compensated liver cirrhosis. These are not breakthrough or unmet clinical benefits but are incrementally advantageous over existing available options, where if proven will reduce the burden of genotype testing of patient before treatment in Indian patients. 3. Further Indian genotypes are different from western genotypes. 4. Moreover, the firm either in their submission or during presentation have not presented the clinical trial data and subset analysis of Asian and/or Indian population (who are residing in foreign countries) and have participated in clinical trial of this drug. Therefore, the firm is required to submit it within seven days to CDSCO for further examination of SEC. In view of above Committee concluded, based on data submitted uptil, that a phase III clinical trial may be conducted specifically to prove the benefits claimed in Indian patients in all genotypes and cases with compensated and decompensated cirrhosis /16-DC (Pt-A) Sofosbuvir and Velpatasvir ( mg) tablets Local clinical trial waiver M/s Natco Pharma Page 2 of 6 The firm has applied for the grant of permission to manufacture and market FDC Sofosbuvir 400mg + Velpatasvir 100mg tablets indicated for the treatment of adult patients with Chronic Hepatitis C Virus, Genotype 1, 2, 3, 4, 5 or 6 infection and requested for waiver of local clinical trial. The Committee deliberated in

3 Page 3 of 6 details the justification of local clinical trial waiver presented by the firm and opined as follows: 1. There is no unmet medical need, as such for various genotype of hepatitis C drug after approval of Sofosbuvir, Ledipasvir and Daclatasvir as single or combination drugs by considering a local clinical trial waiver for these drugs. 2. Present combination proposed to give the benefits as following: I. It is Pangenotypic for HCV infection II. In combination with Ribaverine has shown high response rates in decompensated liver disease patients infected with Hepatitis C Virus and III. Can be used as single therapy for treatment of compensated liver cirrhosis. These are not breakthrough or unmet clinical benefits but are incrementally advantageous over existing available options, where if proven will reduce the burden of genotype testing of patient before treatment in Indian patients. 3. Further Indian genotypes are different from western genotypes. 4. Moreover, the firm either in their submission or during presentation have not presented the clinical trial data and subset analysis of Asian and/or Indian population (who are residing in foreign

4 /16-DC (Pt-B) Sofosbuvir and Velpatasvir ( mg) tablets Local clinical trial waiver M/s Mylan Laboratories Ltd., countries) and have participated in clinical trial of this drug. Therefore, the firm is required to submit it within seven days to CDSCO for further examination of SEC. In view of above Committee concluded, based on data submitted uptil, that a phase III clinical trial may be conducted specifically to prove the benefits claimed in Indian patients in all genotypes and cases with compensated and decompensated cirrhosis. The firm has applied for the grant of permission to manufacture and market FDC Sofosbuvir 400mg + Velpatasvir 100mg tablets indicated for the treatment of chronic hepatitis C (CHC) infection in adults and requested for waiver of local clinical trial. The Committee deliberated in details the justification of local clinical trial waiver presented by the firm and opined as follows: 1. There is no unmet medical need, as such for various genotype of hepatitis C drug after approval of Sofosbuvir, Ledipasvir and Daclatasvir as single or combination drugs by considering a local clinical trial waiver for these drugs. 2. Present combination proposed to give the benefits as following: I. It is Pangenotypic for HCV infection II. In combination with Ribaverine has shown high response rates in decompensated liver disease patients Page 4 of 6

5 infected with Hepatitis C Virus and III. Can be used as single therapy for treatment of compensated liver cirrhosis. These are not breakthrough or unmet clinical benefits but are incrementally advantageous over existing available options, where if proven will reduce the burden of genotype testing of patient before treatment in Indian patients. 3. Further Indian genotypes are different from western genotypes. 4. Moreover, the firm either in their submission or during presentation have not presented the clinical trial data and subset analysis of Asian and/or Indian population (who are residing in foreign countries) and have participated in clinical trial of this drug. Therefore, the firm is required to submit it within seven days to CDSCO for further examination of SEC. In view of above Committee concluded, based on data submitted uptil, that a phase III clinical trial may be conducted specifically to prove the benefits claimed in Indian patients in all genotypes and cases with compensated and decompensated cirrhosis /2016-DC(Pt-Martin & Harris-SND) Diosmin Tablets 900mg Manufacturing and Marketing Subsequent New Drugs Division Proposals M/s Martin & Harris Laboratories Limited Page 5 of 6 Firm presented the phase III CT waiver proposal before the committee. After detailed deliberation, The committee

6 Permission Additional Indication noted that 1. Already formulation containing 900mg of Diosmin and 100mg Hespiridine approved by CDSCO 2. Firm presented the published CT data conducted in Indian population highlighting safety and efficacy of the product 3. The product is already marketed in India more than 10years 4. The same product is approved in EU. The committee recommended the proposed formulation with out local clinical trial /2015-DC(Pt-Sun-SND) Pantoprozole dual release gastro resistant tablets 80mg Phase III CT Permission /2010-DC (Pt-C- vartis) Everolimus tablet 0.25/0.5/0.75/1mg & Dispersibale tablet 0.1/0.25mg Additional Indication Phase IV CT Permission M/s Sun Pharma M/s vartis Firm presented the revised Phase III CT protocol before the committee. Firm modified the protocol as suggested by the earlier committee. The committee recommended the protocol with the condition that the CT site should have ph metry. Firm presented the revised Phase IV CT protocol before the committee. After detailed deliberation the committee opined that a revised protocol including an objective definition of CNI toxicity should be resubmitted before the committee. Page 6 of 6

14 th SEC- Gastroenterology& Hepatology held on at CDSCO (HQ), FDA Bhawan, Kotla road, NewDelhi

14 th SEC- Gastroenterology& Hepatology held on 27-08-2015 at CDSCO (HQ), FDA Bhawan, Kotla road, NewDelhi 110 002 Recommendation:- The 14 th SEC ( Gastroenterology& Hepatology) meeting deliberated the