US FDA approval tracker: September

Snippets

Despite a positive panel meeting Mesoblast’s paediatric graft-versus-host disease treatment Ryoncil still received a knockback from the US FDA, featuring as one of three rejections last month. Still, those concerned that the FDA is tightening up will have been relieved that Gavreto received an early green light in Ret fusion-positive NSCLC. Lilly’s Retevmo is already approved in the setting, but comes with a warning about QT prolongation, something Gavreto’s label does not include. Roche will co-commercialise Gavreto with Blueprint in the US after paying $650m up front for rights. Elsewhere, Glaxosnithkline's Nucala became the first biological approved in the US for hypereosinophilic syndrome, some way ahead of Astrazeneca’s Fasenra, which recently started a pivotal study in this setting. Glaxo is still due a decision on dostarlimab, a latecomer to the anti-PD-1 class, in recurrent endometrial cancer; a decision is expected before the year end. 

Notable first-time US approval decisions in September
Project Company  Sales by indication ($m) Outcome
Dostarlimab Glaxosmithkline 523 No decision yet
Onureg (CC-486) Bristol Myers Squibb 466 Approved
Ryoncil (remestemcel-L) Mesoblast 341 CRL
Alkindi Sprinkle Eton 266 Approved
Libervant Aquestive 197 CRL
Lucassin/terlipressin Mallinckrodt 154 CRL
Gavreto (pralsetinib) Roche/Blueprint 109* Approved (~2 mths early)
Alaway Preservative Free ophthalmic solution (EM-100) Eton/Bausch - Approved
*Forecast doesn’t include Roche numbers. Sources: company releases & EvaluatePharma.

 

Supplementary and other notable approval decisions in September
Product Company Indication (clinical trial) Outcome
Fetroja/Cefiderocol Shionogi Hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia (APEKS-NP) Approved
Trelegy Ellipta Glaxosmithkline Asthma (Captain) Approved
Trulicity Lilly 3mg and 4.5mg doses for type 2 diabetes (Award-11) Approved
Nucala Glaxosmithkline Hypereosinophilic syndrome (NCT02836496) Approved
Kalydeco Vertex Cystic fibrosis patients aged 4-6 months (Arrival) Approved
Xeljanz Pfizer Children & adolescents with active polyarticular course juvenile idiopathic arthritis (NCT02592434) Approved
Xolair Novartis Nasal polyps (Polyp 1 and 2) No decision yet
Sources: Sources: company releases &  EvaluatePharma.

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