Efficacy and Safety

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

Read the bioequivalence data, lymphocyte count data and heart rate data below.

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

Tascenso Fasted bioequivalence graph

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)

Absolute Lymphocyte Count

Absolute Lymphocyte Count (x109/L) Over Time by Treatment Group

Absolute Lymphocyte Count Over Time by Treatment Group.
  • TASCENSO ODT demonstrated similar lowering of lymphocyte counts to Gilenya®.

Heart Rate

Median Change in Heart Rate Over Time by Treatment Group

Mean Change in Heart Rate from Pre-Dose Baseline Over Time by Treatment Group.
  • TASCENSO ODT demonstrated similar effects on the heart rate of Gilenya.
  • There were no differences in adverse events observed between TASCENSO ODT and Gilenya.

Gilenya® is a registered trademark of Novartis AG.

References

1. Data on file: REF-00075.
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