The first month of 2021 saw the approval of Aurinia’s Lupkynis, one of the most valuable launches of the year, according to sellside sales forecasts. The drug, indicated for use in lupus nephritis, is Aurinia’s sole product, and with approval in the bag some believe that the prospect of a takeover has increased. Other approvals of note include an early decision on Exelixis/Ipsen’s Cabometyx in combination with Bristol Myers Squibb’s Opdivo in first-line renal cell carcinoma, which could help cement Opdivo as leader in the space by 2026. Elsewhere, Darzalex Faspro, the subcutaneous version of J&J/Genmab’s anti-CD38 MAb, gained approval in patients with newly diagnosed light-chain (AL) amyloidosis. Jefferies analysts forecast $2bn worldwide peak sales for Darzalex outside multiple myeloma, predominantly in amyloidosis. The other big regulatory news last month was a three-month delay to the FDA’s decision on Biogen’s Alzheimer’s project aducanumab, a move that many interpreted positively and caused Biogen’s shares to rise 5.5%.
| Notable first-time US approval decisions in January | |||
|---|---|---|---|
| Project | Company | 2026e sales by indication ($m) | Outcome |
| Lupkynis (voclosporin) | Aurinia | 1,092 | Approved |
| Cabenuva (cabotegravir + rilpivirine) | GSK/J&J | 681 | Approved |
| Tepmetko (tepotinib) | Merck KGaA | 492 | No decision yet |
| Verquvo (vericiguat) | Merck/Bayer | 389 | Approved |
| Ansofaxine hydrochloride | Luye Pharma | - | No decision yet |
| Vocabria (oral cabotegravir) | Glaxosmithkline | - | Approved |
| Sources: EvaluatePharma & company releases. | |||
| Supplementary and other notable approval decisions in January | |||
|---|---|---|---|
| Product | Company | Indication (clinical trial) | Outcome |
| Xalkori | Pfizer | Paediatric patients with r/r systemic Alk-positive anaplastic large cell lymphoma (study ADVL0912 and A8081013) | Approved |
| Nplate | Amgen | Hematopoietic syndrome of acute radiation syndrome | Approved |
| Enhertu | Astrazeneca | Her2 +ve gastric or gastroesophageal junction (GEJ) adenocarcinoma (Destiny-Gastric01) | Approved |
| Xolair | Roche | Self-administration option across all approved US indications | No decision yet |
| Botox | Abbvie | Detrusor (bladder muscle) overactivity, paediatric patients | No decision yet |
| Estelle | Mithra | Prevent pregnancy | No decision yet |
| Darzalex Faspro | J&J/Genmab | AL amyloidosis (Andromeda, for use in combination with bortezomib, cyclophosphamide and dexamethasone) | Approved |
| Opdivo plus Cabometyx | Bristol/Exelixis | 1L renal cell carcinoma (Checkmate-9ER) | Approved (~1 month early) |
| Sources: EvaluatePharma & company releases. https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-january | |||
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