The Committee deems that the clinical benefit of KYNMOBI (apomorphine hydrochloride) 10 mg, 15 mg, 20 mg, 25 mg, 30 mg sublingual film and treatment initiation pack is substantial in the MA indication.
Clinical Added Value
no clinical added value
Considering:
demonstration of the superiority of apomorphine SL compared to placebo for the mean change from pre-dose in the MDS-UPDRS Part III score at 30 minutes after dosing at Week 12 (primary endpoint): -11.1 points versus -3.5 points, Δ: -7.6 points (95% CI[-11.5; -3.7]; p = 0.0002),
the absence of demonstration of the superiority of apomorphine SL compared to apomorphine SC (reference medicinal product) for the mean change from pre-dose in the MDS-UPDRS Part III score at 90 minutes after dosing at the end of each 4-week sequence (primary endpoint): -13.5 points versus -13.8 points, Δ: 0.3 points (95% CI [-3.16; 3.62]; p = NS), not enabling a conclusion to be reached that the two treatments are equivalent,
the lack of quality of life evidence, in the absence of robust data,
the safety profile of apomorphine SL, marked by specific oropharyngeal adverse reactions,
the Committee deems that KYNMOBI (apomorphine hydrochloride) 10 mg, 15 mg, 20 mg, 25 mg, 30 mg sublingual film and treatment initiation pack provide no clinical added value (CAV V) compared to the reference medicinal product, APOKINON (apomorphine hydrochloride) 30 mg/3 mL solution for injection in pre-filled pen.
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