FDA approval tracker: November

November was a remarkable month for speedy approvals: the FDA green-lit five novel medicines ahead of their respective PDUFA dates. Sickle cell saw two new arrivals: Novartis’s Adakveo, for the prevention of the painful vaso-occlusive crises associated with the disorder, and Global Blood’s Oxbryta, which can boost haemoglobin levels. The latter only has conditional approval, with a confirmatory trial needed to answer questions about its impact on longer term outcomes. Meanwhile Alnylam gained approval of its second RNAi drug, Givlaari, and Beigene received its first ever US approval with the BTK inhibitor Brukinsa. Brukinsa can be used as a second-line treatment for mantle cell lymphoma; it is also being tested in the much larger indication of chronic lymphocytic leukaemia with initial cohort data from the phase III Sequoia trial due at Ash. At the other end of the spectrum is Lipocine, which received a third complete response letter for its hypogonadism treatment Tlando; shares crashed 71% on the news. Meanwhile Agile, which has also received two CRLs for its contraceptive patch Twirla, will have to wait a little longer: the projects PDUFA date has been delayed until February.

Notable first-time US approval decisions in November
Project Company NPV ($m)* Outcome Vantage coverage
Brukinsa/ zanubrutinib** Beigene 6,649*** Approved (3 months ahead of PDUFA date)  
Oxbryta/ voxelotor** Global Blood Therapeutics 4,925 Approved (3 months ahead of PDUFA date) Global Blood’s sickle cell approval is no guarantee of success
Reblozyl/ luspatercept** Acceleron/ Bristol-Myers Squibb 3,892 Approved (1 month ahead of PDUFA date)  
Adakveo/ crizanlizumab** Novartis 1,599 Approved (2 months ahead of PDUFA date) Novartis’s win in sickle cell could scythe Global Blood’s ambitions
Givlaari/ givosiran** Alnylam 1,495 Approved (2.5 months ahead of PDUFA date) Speedy nod sets Alnylam up for its second launch
Tlando Lipocine 365 CRL  
Fetroja/
S-649266
Shionogi 242 Approved  
Twirla Agile Therapeutics 212 Delayed to Feb 16, 2020  
Zimhi Adamis 85 CRL (decision delayed from October)  
Talicia Redhill Biopharma 57 Approved  
Exservan Aquestive Therapeutics 2 Approved  
Xcopri/ cenobamate SK Life Science - Approved  
*NPV data as of November 29, EvaluatePharma.**Not in October story. Source: Go or no go? Agile and Lipocine hope to make it third time lucky, October 31, 2019. ***NPV reflects approval and use in other indications in the future.

 

Supplementary and other notable approval decisions in November
Project Company Event type Outcome
Tradjenta Boehringer Ingelheim/Lilly  sNDA for cardiovascular risk reduction in type 2 diabetes No decision yet
Fluzone Quadrivalent Sanofi sBLA for influenza vaccine in pts ≥65 – high dose Approved
Abrilada/
PF-06410293
Pfizer   Biosimilar Humira Approved
Xtandi Pfizer/
Astellas Pharma
sNDA for metastatic hormone-sensitive prostate cancer No decision yet
Ziextenzo* Novartis Biosimilar Neulasta Approved
Calquence* Astrazeneca sNDA for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma Approved
*Not in October story. Source: Go or no go? Agile and Lipocine hope to make it third time lucky, October 31, 2019.

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