Bioequivalence

Under the FDA’s 505(b)(2) pathway, TASCENSO ODT was shown to have the same pharmacokinetics (PK) profile as Gilenya® (fingolimod) capsules, meaning the rate and extent of exposure of the drug is the same for both formulations. Therefore, the two products are considered bioequivalent.1

  • Same proven fingolimod
  • Same safety, same efficacy and the same side effects
  • Not a generic2

Not only could the unique formulation of TASCENSO ODT be well suited to your patients, it also means TASCENSO ODT cannot be substituted by Gilenya® or generic fingolimod at the pharmacy level.

Find out more about taking TASCENSO ODT

Bioequivalence Studies

Fasted Study1

  • Single center, randomized, single dose, laboratory blinded, single period, 3-treatment, 3-arm parallel study
  • Test: TASCENSO ODT – 1 mg (2 x 0.5 mg ODT)
  • Reference: Gilenya® – 1 mg (2 x 0.5 mg oral capsule)
  • Treatment 1: 25 participants, single 1 mg dose of Test product, orally administered with 240 mL of water in the morning
  • Treatment 2: 25 participants, single 1 mg dose of Test product, orally administered without water in the morning
  • Treatment 3: 25 participants, single 1 mg dose of Reference product, orally administered with 240 mL of water in the morning

Bioequivalence data of Gilenya® (fingolimod) capsules 0.5 mg and TASCENSO ODT® (fingolimod) orally disintegrating tablets 0.5 mg, with and without water, under fasting conditions

Bioequivalence data of Gilenya® (fingolimod) capsules 0.5 mg and TASCENSO ODT® (fingolimod) orally disintegrating tablets 0.5 mg, with and without water, under fasting conditions

PK and Statistical Results

FINGOLIMOD
PK Parameter 		TASCENSO ODT w/o water
Geometric Mean
Fasted 		Gilenya® w/ water
Geometric Mean
Fasted 		Geometric Mean
Ratio (90% CI)
target 80-125%
Tmax(h)
(min-max) 		32.00
(10.00 – 58.87) 		28.00
(12.00 – 59.03) 		N/A
Cmax(pg/mL)
(SD) 		689.0
(96.1) 		761.6
(112.8) 		90.54 (84.64-96.98)
AUC0-144(pg.h/mL)
(SD) 		70875.8
(10224.8) 		77952.1
(12029.5) 		91.09 (84.66-98.01)
FINGOLIMOD
PK Parameter 		TASCENSO ODT w/
water
Geometric Mean
Fasted 		Gilenya® w/o
water
Geometric Mean
Fasted 		Geometric Mean
Ratio (90% CI)
target 80-125%
Tmax(h)
(min-max) 		32.00
(12.00 – 59.82) 		32.00
(10.00 – 58.87) 		N/A
Cmax(pg/mL)
(SD) 		722.7
(126.9) 		689.0
(96.1) 		104.33 (96.71-112.56)
AUC0-144(pg.h/mL)
(SD) 		74521.7
(15219.5) 		70875.8
(10224.8) 		104.19 (95.89-113.21)

Fed Study1

  • Single center, randomized, single dose, laboratory blinded, single period, 2-treatment, 2-arm parallel study
  • Test: TASCENSO ODT – 1 mg (2 x 0.5 mg ODT) Reference: Gilenya® – 1 mg (2 x .5 mg oral capsule)
  • Treatment 1: 19 participants, single 1 mg dose of Test product, orally administered without water under fed conditions
  • Treatment 2: 19 participants, single 1 mg dose of Reference product, orally administered with 240 mL of water under fed conditions

Bioequivalence data of Gilenya® (fingolimod) capsules 0.5 mg and TASCENSO ODT® (fingolimod) orally disintegrating tablets 0.5 mg, under fed conditions

 

Bioequivalence data of Gilenya® (fingolimod) capsules 0.5 mg and TASCENSO ODT® (fingolimod) orally disintegrating tablets 0.5 mg, under fed conditions

PK and Statistical Results

FINGOLIMOD
PK Parameter 		TASCENSO ODT w/o water
Geometric Mean
Fasted 		Gilenya® w/ water
Geometric Mean
Fasted 		Geometric Mean
Ratio (90% CI)
target 80-125%
Tmax(h)
(min-max) 		32.00
(6.00 – 59.70) 		32.00
(28.00 – 59.43) 		N/A
Cmax(pg/mL)
(SD) 		725.3
(105.6) 		760.1
(112.8) 		96.44 (88.07-103.44)
AUC0-144(pg.h/mL)
(SD) 		73410.6
(12275.8) 		79341.3
(14030.8) 		92.63 (84.63-101.73)
Find out more about taking TASCENSO ODT
Enroll your patients now

Gilenya® is a registered trademark of Novartis AG.

References

1. Data on file: REF-00069.
2. FDA., 2022. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed January 3rd 2023. Available: www.accessdata.fda.gov/scripts/cder/ob/index.cfm