US FDA approval tracker: January 2021

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
Aurinia 1,092 Approved
Cabenuva (cabotegravir + rilpivirine) GSK/J&J 681 Approved
Merck KGaA 492 No decision yet
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.

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