
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. |