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. https://www.evaluate.com/vantage/articles/events/company-events-snippets/go-or-no-go-biogen-and-astellas-head-towards-key | |||
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