US approval tracker: January 2023

Last month was a tale of two Alzheimer's MAbs, with celebrations for Eisai and commiserations for Lilly. Eisai’s lecanemab, now branded Leqembi, gained an accelerated approval in Alzheimer’s patients with mild cognitive impairment or mild dementia. A day after the greenlight Eisai filed for full approval. Lilly’s donanemab, on the other hand, was knocked back, as the filing did not include enough patients with at least 12 months' exposure to the MAb. Donanemab’s confirmatory phase 3 data are due mid-year. In oncology there were a couple of approval firsts in Menarini’s oral Serd Orserdu and Lilly’s non-covalent BTK inhibitor Jaypirca. Also in oncology, Beigene’s covalent BTK inhibitor Brukinsa added chronic lymphocytic leukaemia to its label. The label includes a superiority claim over Johnson & Johnson/Abbvie’s Imbruvica on overall response rate, and Beigene is planning to submit a post-approval labelling supplement to get PFS superiority added. The latter could help Brukinsa take market share from Astrazeneca’s Calquence, which has only demonstrated non-inferiority to Imbruvica.

Notable first-time US approval decisions in January
Project Company Indication(s) 2028e SBI ($m) Outcome
Donanemab Lilly Early symptomatic Alzheimer's disease 1,872* CRL
Leqembi (lecanemab) Eisai/Biogen Alzheimer's disease 1,854 Approved (accelerated)
Orserdu (elacestrant) Menarini (private)/
2L and 3L ER+/Her2- advanced/metastatic breast cancer - Approved (~2 weeks early)
Jaypirca (pirtobrutinib) Lilly/Loxo Mantle cell lymphoma for patients previously treated with a BTK inhibitor -** Approved
Airsupra (PT027) Astrazeneca/ Avillion As-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in asthma pts aged ≥18 - Approved in adults; CRL in children aged 4-17 (negative adcom in November)
Brenzavvy (bexagliflozin) Theracosbio Adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes - Approved
*Forecast prior to CRL, **sales assigned to CLL. SBI: sales by indication. Source: Evaluate Pharma, company releases.


Advisory committee meetings in January
Project Company Indication 2028e SBI ($m) Outcome
Rezafungin Cidara/
Candidemia and invasive candidiasis in adults 348 14-1 in favour, in adults with limited or no alternative treatment options (Pdufa Mar 22)
Eylea Regeneron Retinopathy of prematurity in preterm infants - No vote; discussions were around appropriate communication and labelling. No anti-VEGF treatments have been approved in the US for the indication but several are used off-label (Pdufa Feb 11)
- - Future Covid-19 vaccination regimens - Recommended that all future vaccines should be bivalent. Another meeting will take place in May/June to discuss the latest variant data and whether the current booster shots will be sufficient for the autumn
Source: Evaluate Pharma, company releases, FDA adcom calendar.


Supplementary and other notable approval decisions in January
Product Company Indication (clinical trial) Outcome
Vonaprazan (Takecab) Phathom Erosive oesophagitis (Phalcon-ee) Delayed (impurity found in commercial batches, additional stability data needed. Also affects approved H pylori indication)
Tukysa + Herceptin Seagen Adult patients with Her2-positive colorectal cancer who have received at least 1 prior treatment regimen for unresectable or metastatic disease (Ph2 Mountaineer) Approved (accelerated)
Brukinsa Beigene Adults with CLL or SLL (Alpine, Sequoia) Approved
Keytruda Merck & Co Adjuvant therapy for Stage IB (≥4 cm)-IIIA NSCLC following complete resection (Pearls/Keynote-091) Approved
Myfembree Pfizer/Myovant Update to prescribing information (heavy menstrual bleeding associated with uterine fibroids) based on safety and efficacy data from the Liberty randomised withdrawal study Approved
Rybelsus Novo Nordisk 1L treatment option for adults with type 2 diabetes Approved
Rykindo (risperidone for extended-release injectable suspension) Luye Pharma Schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults Approved
Vabysmo Roche Include two-year data from Yosemite and Rhine studies in diabetic macular oedema Approved
Evusheld Astrazeneca Pre-exposure prophylaxis of Covid-19 EUA removed due to lack of efficacy against circulating variants
Acalabrutinib (generic to Astrazeneca's Calquence) Alembic Pharms Mantle cell lymphoma (after at least one prior therapy) and chronic lymphocytic leukaemia or small lymphocytic lymphoma  Tentative approval
Insugen (rh-insulin) (biosimilar) Biocon Diabetes CRL (additional data, inspection issues)
Source: Evaluate Pharma, company releases.

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