19thSEC- (Endocrinology) meeting held on 28-04-2015 at CDSCO (HQ),
FDA Bhawan, Kotla Road, New Delhi – 110 002
Recommendation:The 19th SEC (Endocrinology) Meeting deliberated the proposals on 28-04-2015 and
recommended the following:-
Age
nda
No
File Name &Drug
name, Strength
Firm Name
Recommendations
New Drug Division
1
12-65/13-dc
Teneligliptin 20mg
Tablets
2
12-47/14-DC(Pt.A)
Anagliptin 100mg
Tablets
M/s Glenmark
pharmaceutical
M/s Intas
The firm made application for grant of
permission to manufacture & market
Teneligliptin 20 mg tablets for the
treatment of Type-2 Diabetes Mellitus. The
firm presented the clinical trial study report
and BE study report in the SEC meeting
held on 28.04.2015. After the detailed
deliberation, the SEC recommended the
manufacturing and marketing permission
of
Teneligliptin 20 mg tablets for the
treatment of Type-2 Diabetes Mellitus as a
monotherapy adjunct to diet and exercise.
The firm has applied for grant of
permission to conduct a Phase-III clinical
trial of Anagliptin in Type-2 Diabetes
Mellitus patients. The firm presented the
protocol. The Committee deliberated in
detail the protocol and recommended to
amend the protocol with respect to the
following and present the same before the
Committee for review:
1. The trial should be double blinded
and with two sided significance.
2. The lower limit of the Metformin
dose in inclusion criteria should be
specified.
3. The words” in the opinion of the
Investigator “ wherever mentioned
in the protocol should be omitted
and objective criteria should be
mentioned.
4. Patients in insulin therapy for more
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19thEndocrinology 28-04-2015
than three months at any time
during disease duration should be
excluded.
5. A visit week 8 should be scheduled.
6. ECG should be included in safety
assessment.
7. 2-D/Echo should be done in all
patients at baseline and at
completion of the study.
8. In the inclusion criteria the fasting
plasma glucose level should be
≤200mg/Dl.
9. Rescue criteria to be defined in the
protocol.
10. All the laboratory tests which the
study population are going to be
undergo needs to be clearly defined
in the protocol.
The Committee approved the BE protocol
for conducting the BE study.
3
4
5
6
Biological Division
4-147/Sandor/PAC-R- M/s. Sandor
After detailed deliberation committee
Alglucosidase alfa/14- Medicaids Pvt.
recommended for approval of updated
BD
Limited.
prescribing information for Alglucosidase
Alglucosidase alfa
alfa Injection (Myozyme) including change
in Posology section from Pediatric and
elderly population to Paediatric and older
people and other changes.
4-243/EliLilly/14-BD M/s Eli Lilly
After deliberation the committee in the
Dulaglutide
opinion that the firm’s request for change
in the warning statement cannot be
considered at this stage. The firm is
required to submit atleast 1 year PMS data
after approval of PMS study for taking
further necessary action in this matter .
4M/s NovoNordisk
After deliberation the committee in the
131/NovoNordisk/12opinion that the firm’s request for change
BD
in the warning statement cannot be
Insulin Degulecconsidered at this stage. The firm is
Tresiba®
required to submit at least 1 year PMS data
of Indian Patients after approval of PMS
study for taking further necessary action in
this matter .
4-309/Novo Nordisk/15-M/s NovoNordisk
After detailed deliberation the committee is
BD
in the opinion that in view of large amount
Insulindegludec/liraglutid
of data to be scrutinized, expert of the
e (IDegLira)
committee wanted more time to review the
data to take appropriate decision in the
matter. It was also observed that there is no
Bioequivalence study (PK/PD) carried out
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19thEndocrinology 28-04-2015
in Indian Population. Accordingly, the
proposal of firm will be discussed in the
subsequent SEC meeting.
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19thEndocrinology 28-04-2015