Go or no go? Biogen and Astellas head towards key Pdufas

Two of this year’s biggest FDA approval decisions are due next month, that of Astellas’s Zimura and Biogen/Sage’s zuranolone. The latter is filed in major depressive disorder and postpartum depression and is expected to be approved. Zuranolone is forecast to be Biogen's biggest growth driver but questions remain on its commercial prospects given its short two-week course of therapy. Biogen needs to reinvigorate investor sentiment after announcing job cuts on its recent second quarter call, today it disclosed a hefty buyout of Reata. For Astellas, Zimura was gained through its $5.9bn acquisition of Iveric Bio, and is intended to treat geographic atrophy. On a cross-trial basis Zimura, a complement factor C5 inhibitor, looks fairly similar to Apellis’s approved Syfovre that targets C3. Syfovre got off to a strong launch in March but confidence in the therapy was knocked recently after six cases of retinal vasculitis were reported. The safety issue was not evident in clinical studies and could be related to manufacturing or delivery, noted TD Cowen analysts, leaving room for Zimura to pile on the pressure. More safety details are expected at this weekend's American society of retina specialists meeting.

Notable first-time US approval decisions due in August 2023
Project Company Pdufa date Indication(s) 2028e SBI ($m) Note
Ryoncil (remestemcel-L) Mesoblast/ JCR Pharmaceuticals 2 Aug (resubmission) Children with steroid-refractory acute graft versus host disease 223 Mesoblast can’t catch a break
PDP-716 (0.35% brimonidine tartrate) Visiox 4 Aug Glaucoma - -
Zuranolone Biogen/Sage 5 Aug Major depressive disorder and postpartum depression 1,177 See text
Talvey (talquetamab) J&J Estimated 9 Aug Relapsed or refractory multiple myeloma 300 Bispecific T-cell engager antibody targeting both GPRC5D and CD3
Avasopasem Galera 9 Aug Radiotherapy-induced severe oral mucositis - Selective dismutase mimetic
Hepzato kit Delcath 14 Aug (resubmission) Unresectable hepatic-dominant metastatic ocular melanoma - Previous CRL in 2013, after a negative adcom, needed another trial
Sohonos (palovarotene capsules) Ipsen 16 Aug (resubmission) Fibrodysplasia ossificans progressiva - After an earlier CRL received a positive adcom
Zimura Astellas (Iveric Bio) 19 Aug Geographic atrophy 1,179 See text
Pozelimab Regeneron 20 Aug Adults and children as young as 1 year of age with Chaple disease - Subcutaneous anti-complement C5 antibody
Elranatamab Pfizer Estimated 22 Aug Relapsed or refractory multiple myeloma  829 BCMA T-cell engager
Lytenava (ONS-5010) Outlook 29 Aug Wet AMD 590 Opthalmic Avastin
VLA1553 Valneva End of Aug Single-shot chikungunya vaccine 333 Bavarian falls short of Valneva in Chikungunya
Tuoyi (toripalimab) Coherus Q3 Nasopharyngeal carcinoma - Previous inspection delays
Pombiliti + Opfolda Amicus Q3 Adults with late-onset Pompe disease 443 Previous inspection delays
Bimzelx UCB Q3 (resubmission) Plaque psoriasis 937 Delayed from Q2 to Q3, previous CRL due to failed pre-approval inspections
Etrasimod Pfizer H2 Ulcerative colitis 825 S1P inhibitor, competitor to Bristol's Zeposia (Pfizer seeks to put etrasimod first)
SBI: sales by indication. Sources: Evaluate Pharma & company releases.


Supplementary and other notable approval decisions due in August 2023
Product Company Indication (clinical trial) Date
Abrysvo Pfizer Prevention of (severe) lower respiratory tract disease caused by RSV in infants from birth through 6 months by active immunisation of pregnant individuals Aug
Lonsurf Taiho/Otsuka Monotherapy or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (Sunlight) 13 Aug
Daxxify Revance Cervical dystonia (Aspen-1, Aspen OLS) 19 Aug
Ingrezza Neurocrine Chorea associated with Huntington disease (Kinect-HD, Kinect-HD2) 20 Aug
Reblozyl Bristol First-line treatment of anaemia in lower risk myelodysplastic syndromes 28 Aug
Jardiance Lilly/Boehringer Reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (Empa-Kidney) Estimated Q3
AVT04 (Stelara biosimilar) Alvotech/Teva Inflammatory conditions H2
Cosentyx Novartis Hidradenitis suppurativa (Sunshine, Sunrise) H2
Intravenous Cosentyx Novartis Adult patients with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis (Invigorate 1, Invigorate 2) H2
Sources: Evaluate Pharma & company releases.

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