Twelve medicines cleared a single committee meeting, and two of them change what a particular day looks like for a particular person.
The European Medicines Agency's Committee for Medicinal Products for Human Use met July 20 to 23 and recommended twelve medicines for approval, plus eight extensions of indication for drugs already on the market [1].
Susvimo is a refillable ocular implant for wet age-related macular degeneration - the first of its kind recommended in the EU [1]. The current standard for wet AMD is an injection into the eye, monthly, indefinitely. An implant that is refilled instead removes most of those appointments.
Nezglyal (leriglitazone) is an orphan medicine for cerebral adrenoleukodystrophy [1] - a degenerative brain disease that strikes children and for which there has been almost nothing available. Orphan designations exist precisely because the market will not produce these on its own.
Also recommended: Lyrokaul (lerodalcibep), a monthly self-injected cholesterol treatment; Zokovea (ensitrelvir); Icotyde (icotrokinra); and Lynavoy (linerixibat) [1]. Three separate cholesterol drugs cleared the meeting.
Two things keep this honest. A CHMP opinion is a recommendation - the European Commission grants the actual marketing authorisation, usually within about 67 days. Nothing here is approved yet.
The same meeting also issued three negative opinions and recorded three withdrawals [1]. A committee that only ever said yes would not be worth reporting when it says yes.
