US FDA approval tracker: December 2019

The FDA’s run of speedy approvals continued in the last month of 2019. Two antibody-drug conjugates, Seattle’s Padcev and Astra/Daiichi’s Enhertu, came early, alongside Newlink/Merck’s Ebola vaccine Ervebo. Approval of Sarepta’s second Duchenne’s therapy, Vyondys 53, came out of the blue mid-month, reversing a previous complete response letter, while Intracellular’s shares rocketed 193% after its schizophrenia treatment Caplyta got the green light despite mixed clinical data. Amarin's Vascepa gained a broad cardiovascular label including a primary prevention setting; however, risk from litigation and upcoming competition overhangs this drug. Allergan’s Ubrelvy became the first oral CGRP antagonist for acute migraine, but Biohaven’s competing offering has its own PDUFA date set for early 2020. Meanwhile, Enzyvant’s RVT-802, a regenerative tissue therapy in development for congenital athymia, was knocked back owing to manufacturing concerns – not a great start to the $3bn strategic alliance Sumitomo Dainippon signed with Roivant, Enzyvant’s holding company, back in September.

Notable first-time US approval decisions in December
Project Company Product NPV ($m)* Outcome Vantage coverage
Subcutaneous Entyvio** Takeda 13,353 (franchise) CRL  
Enhertu (trastuzumab deruxtecan)** Astrazeneca/Daiichi Sankyo 6,502 Approved (4 mths early) Go or no go? Enhertu’s destiny revealed and FDA decisions due for Epizyme, Novo
Padcev (enfortumab vedotin)** Seattle Genetics/Astellas 4,693 Approved (3 mths early)  
Caplyta (lumateperone) Intra-Cellular Therapeutics 2,069 Approved Intra-cellular triples on schizophrenia approval
Cabotegravir & Rilpivirine Shionogi/GSK 1,837 CRL  
Ubrelvy (ubrogepant) Allergan 708 Approved Ubrelvy's a winner, but not for long
Dayvigo (lemborexant) Eisai 625 Approved  
Brinavess Correvio Pharma 510 CRL  
Vyondys 53 (golodirsen)** Sarepta 359 Approved Sarepta proves the doubters wrong – again
AV001 Avadel 7 Approved  
RVT-802 Enzyvant - CRL  
Arazlo (tazarotene) Bausch Health Companies - Approved  
Ervebo/Zaire Ebola virus vaccine V920** Newlink/Merck - Approved (3 mths early)  
*NPV data as of December 30, via EvaluatePharma. **Not in December story. Source: Go or no go? Vascepa’s finale and Allergan's pain relief, December 2, 2019.


Supplementary and other notable approval decisions in December
Product Company Event type Outcome Vantage coverage
Tecentriq Roche sBLA + Abraxane for first-line non-squamous NSCLC (Impower-130) Approved  
Avsola/ABP 710 Amgen Biosimilar Remicade Approved  
Vascepa Amarin sNDA for Cardiovascular outcomes (Reduce-It) Approved Litigation risk still overhangs the Amarin takeover thesis
Xtandi Astellas Pharma sNDA for metastatic hormone sensitive prostate cancer (Arches) Approved  
Lynparza Astrazeneca sNDA for BRCAm pancreatic cancer (Polo) Approved Asco 2019 – Polo reveals an overall survival hole
Source: Go or no go? Vascepa’s finale and Allergan's pain relief, December 2, 2019.

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