M/s. Hetero Labs Ltd.

Transcription

1 Recommendations: I approve the minutes of 38 th SEC (Cardiovascular & Renal) held on at CDSCO HQ New Delhi and recommended the following: Agenda New Drugs Division /16-DC Azilsartanmedoxomil 40mg + Chlorthalidone 12.5mg tablets /16-DC (Pt-A) Azilsartanmedoxomil 40mg + Chlorthalidone 12.5mg tablets M/s. Hetero Labs Ltd. M/s. Ajanta Pharma Subsequent New Drugs Division The firm presented the proposed Phase III clinical trial protocol. After detailed deliberation the Committee recommended the study with the following amendments in the protocol:- 1. Only denovo hypertensive patients to be included. 2. The screening period should not be more than week. 3. The evaluable sample size should be minimum 300. Accordingly, firm should submit revised clinical trial protocol to the office of DCG (I). Firm shall complete Bioequivalence study before initiation of clinical trial. The firm presented the proposed Phase III clinical trial protocol. After detailed deliberation the Committee recommended the study subject to the condition that the evaluable sample size should be minimum 300. Accordingly, firm should submit revised clinical trial protocol to the office of DCG (I). Firm shall complete Bioequivalence study before initiation of clinical trial /2015-DC (Pt-Sun- SND)Sildenafil for oral suspension 10mg/mL M/s Sun Pharma Firm presented the BE report. The data was found satisfactory. After detailed Page 1 of 8

2 4 CT/06/17Pemafibrate Global Clinical Trial Division M/s. Quintiles Page 2 of 8 deliberation the committee recommended proposed formulation to be marketed in the country. Risk versus benefit to the patient: The pre-clinical including repeat dose studies and Phase I, Phase II, Phase III studies justify the conduct of this study. Innovations Vs existing therapeutic option: The primary scientific aim of this study is to assess whether treatment with selective peroxisome proliferator activated receptor modulator alpha (SPPARM-alpha) IMP, will prevent myocardial infarction (MI), ischemic stroke, unstable angina requiring unplanned revascularization and cardiovascular death in adults with T2D who have elevated TG and low HCL- C levels and are at high risk for future CV events. Unmet medical need in the country: Reducing the rate of diabetes related complications requires more than just adequate glycemic control, and to ameliorate residual macrovascular risk, lipid management may require more than statins alone. The specificity of increased CV risk due to metabolic syndrome, T2D, increased TG and decreased HDL-C make South Asian populations in need of new effective treatments for these conditions as well as an ideal clinical setting to address the scientific hypothesis tested with IMP. After detailed deliberation the committee recommended the conduct of the Phase 3 clinical trial

3 5 CT/54/16 LNP 1892 M/s. Lupin Page 3 of 8 as per the protocol presented. Assessment of Risk versus benefit to the patients: In Phase 1 first in human study, IMP was found to be safe and well tolerated up to the highest doses tested (up to 50 mg in single dose and 25 mg in multiple dose study). IMP has potential to decrease ipth without significant hypocalcaemia. The observation of preclinical and Phase I clinical study justify the conduct of study. Innovation Vis-à- Vis existing therapeutic option: In current available therapies for SHPT, phosphate binders have a risk of cardiovascular diseases (CVD), and newer vitamin D sterols have a risk of hypercalcemia and provide inefficient control. It is expected that the property of IMP of reducing ipth without change in serum phosphate or calcium levels will benefit in SHPT patients who are on dialysis as well as not on dialysis. Unmet medical need in the country: In India, prevalence of SHPT is very common varying from 72.7% to 92.5%, increasing with CKD stage, and maximum seen in CKD Stage 5. Cinacalcet is the first US FDA approved calcimimetic for treating SHPT in CKD patients receiving dialysis (stage 5 CKD) and hypercalcemia in patients with parathyroid carcinoma. Cinacalcetis also not recommended in patients with intact parathyroid

4 6 CT/57/16 Sodium Zirconium cyclosilicate M/S. AstraZeneca hormone (ipth) values above 800 pg/ml and who are Not on Dialysis. There is therefore, an urgent need for new pharmacologic therapies that achieve a balanced control of mineral metabolism and PTH secretion in SHPT in Dialysis as well as Not on Dialysis patients. After detailed deliberation the committee has recommended the conduct of the Phase 2 study. Assessment of Risk versus benefit to the patients The observations of preclinical, clinical Phase I, Phase II and Phase III study justify the conduct of study. Innovation Vis-à- Vis existing therapeutic option The study design aims to minimize potential risks; intensive monitoring, including early safety assessment, is in place for those risks deemed to be most likely based on prior experience with the drugs. Unmet medical need in the country The only pharmacologic modality that actually increases elimination of potassium fromthe body is SPS.SPS causes severe gastrointestinal (GI) sideeffects, most notably profuse diarrhoeaand has been associatedwith fatal colonic necrosis. After detailed deliberation the committee opined that the study cannot be recommended in the present form due to the following reasons: 1) The presumption in Page 4 of 8

5 the protocol presented that most of the patients being managed for acute hyperkalaemia continue to require treatment by maintenance phase is not based on scientific facts. 2) The protocol also has no clarity on diet and concomitant medication affecting the serum potassium level during the duration of trial. Accordingly the firm should submit revised protocol for further deliberation. Fixed Dose Combination /2016-DC (Pt. Sun)OlmesartanMedoxomil IP + Chlorothalidone IP + Cilnidipine (20mg/40mg+12.5mg+10mg) /2016 DCMetoprololTartrate+Ivabradine eq. to Ivabradine Hydrochloride (25mg /50mg+5.390mg/5.390mg) M/s. Sun Pharma Laboratories M/s. Serdia Pharmaceuticals Page 5 of 8 The firm presented phase IV trial protocol on the FDC before the Committee. The Committee observed that the same Combination with Chlorthalidone with 6.25 mg was considered by the Kokate Committee and asked for Phase IV clinical trial study. Such combination with other sartans has already approved by DCGI. In the light of above the Committee recommended for manufacturing and marketing and conduct the phase IV clinical trial study as presented. The firm presented proposal before the Committee. The Committee opined that the firm did not produce any clinical study with the FDC therefore the Committee recommended to conduct

6 MD/2007-DC ((RE- Reg.03) Bioresorbable Vascular Scaffold (BVS) 10 4-MD/CT-180/2016-DC Excimer Laser Coronary Atherectomy (ELCA): Coronary Laser Atherectomy Catheters (OTW & RX) Medical Device Division M/s. Abbott Healthcare Pvt. Ltd, Delhi M/s. CBCC-VIBGYOR Research Pvt. Ltd Biological Division Phase III clinical study with the FDC to prove safety and efficacy of the product in Indian populations and accordingly firm should submit study protocol for further deliberation by the Committee. The committee has reviewed the safety data of ABSORB BVS generated in India. The committee gives the following recommendations 1. All stake holders specially the interventional cardiologists regarding the advisory issued by US FDA and European Union MHRA and TGA 2. The sale should be restricted to the experienced operators and high volume centres. 3. Proper implantation technique has to be followed by each centre 4. BVS should not be implanted in vessel size less than 2.5 mm 5. The firm has to come up with future plan and each patient implanted has to be systematically followed up in a registry/phase IV trial and protocol has to be submitted for examination and approval. The firm presented the protocol before the experts. The committee recommended the approval of the proposed protocol and conduct of clinical trial. Page 6 of 8

7 /Hetero/PAC/R- Darbepoetin/17-BDDarbepoetin alfa M/s. Hetero Drugs Ltd After detail deliberation of the proposal of additional strength (10 µg/0.4 ml, 15 µg/0.375 ml and 20 µg/0.50 ml) and intravenous route, including proposed and all previously approved strength, committee recommended for the marketing authorization. Page 7 of 8

8 S.No SEC Experts Name & Designation Signature 1. Dr.V K Bahl, Prof. & Head Of Deptt. Of Cardiology, AIIMS, Ansari Nagar, New Delhi. 2. Dr.SandeepBansal, Professor & Head of Department of Cardiology, VardhmanMahavir Medical College, New Delhi Dr. K.M.K Reddy, DM Cardio, Osmania Medical College, Secunderabad, Andhra Pradesh 4. Dr. R K Sharma, Professor, Dept. Of Nephrology SGPGI, Lucknow. 5. Dr.Shashi Mohan Sharma, Professor, Deptt. Of Cardiology, SMS Medical College & Attached Hospitals, J.L.N. Marg, Jaipur Rajasthan India. 6. Dr. S.K. Agrawal, Professor & Head of the department, Dept. Of Nephrology AIIMS, New Delhi. 7. Dr. K. H. Reeta, Department of Pharmacology, AIIMS, New Delhi. 8. Dr.SaibalMukhopadhyay, Assoc. Professor, Deptt. Of Cardiology, G B Pant Hospital, Delhi. Page 8 of 8