FDA ap­proves po­ten­tial block­buster in­som­nia drug, a first for Swiss biotech Idor­sia

The FDA on Mon­day ap­proved Swiss biotech Idor­sia’s first drug, known com­mer­cial­ly as Qu­viviq, for the treat­ment of adults with in­som­nia.

The road to ap­proval for this dual orex­in re­cep­tor an­tag­o­nist (DO­RA) called dari­dorex­ant has been lined with most­ly pos­i­tive late-stage tri­als, with both of the ap­proved dos­es — 25 mg and 50 mg — show­ing sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in polysomnog­ra­phy and self-re­port­ed to­tal sleep at dif­fer­ent stages in one of the two piv­otal tri­als.

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