
US FDA approval tracker: October 2019
It was a case of tales of the unexpected last month with the early approval of Vertex’s triplet Trikafta. The cystic fibrosis drug is the most valuable product to get the nod in October, according to EvaluatePharma, which puts its NPV at $17bn. However, controversies remain over Trikafta’s pricing: at $311,000 per patient per year it is 6% and 14% above the cost of Vertex's older cystic fibrosis doublets Symdeko and Orkambi respectively. Meanwhile, Novartis has set the price for its now-approved eye drug Beovu about in line with the established age-related macular degeneration therapy Eylea. However, the Swiss group might find it hard to take market share from the Regeneron and Bayer megablockbuster, especially as there are concerns about intraocular inflammation with Beovu. Biogen also received the thumbs up for its Tecfidera follow-on, Vumerity, but will now need to move patients onto the new drug before Tecfidera generics hit. Two key patent challenges are approaching, with a district court hearing due in December and an inter partes review set for February.
Notable first-time US approval decisions in October | ||||
---|---|---|---|---|
Project | Company | Product NPV ($m)* | Outcome | Vantage coverage |
Trikafta** (elexacaftor, tezacaftor and ivacaftor) | Vertex | 17,060 | Approved | Vertex’s double cystic fibrosis surprise |
Beovu/brolucizumab | Novartis | 5,817 | Approved | Novartis prices Beovu on a par with Eylea |
Breztri Aerosphere/PT010** | Astrazeneca | 1,672 | CRL | New clinical data request hits Astra’s lung triplet |
Reyvow/lasmitidan** | Eli Lilly | 1,123 | Approved | Lack of drive could slow down Reyvow sales |
Vumerity | Alkermes/Biogen | 604 | Approved | |
Xipere | Clearside Biomedical | 212 | CRL | |
Amzeeq/FMX-101 | Foamix Pharmaceuticals | 96 | Approved | |
Zimhi | Adamis Pharmaceuticals | 84 | No decision yet | |
Cosyntropin | Assertio Therapeutics | 74 | CRL | |
Scenesse | Clinuvel Pharmaceuticals | 46 | Approved | |
Biorphen/ET-202 | Eton Pharmceuticals | - | Approved | |
Aklief/trifarotene cream** | Galderma | - | Approved | |
*NPV data as of October 30, EvaluatePharma.**Not in September story. Source: Go or no go? Novartis eyes a big new growth driver, September 27, 2019. |
Supplementary and other notable approval decisions in October | |||
---|---|---|---|
Product | Company | Event type | Outcome |
Descovy | Gilead Sciences | sNDA for HIV pre-exposure prophylaxis (PrEP) | Approved (in men and transgender men, not cisgender women) |
PF708 | Pfenex | Biosimilar Forteo | Approved |
Zilretta | Flexion Therapeutics | sNDA for repeat administration for osteoarthritis pain | Extended, no new date given |
Xarelto | Johnson & Johnson/Bayer | sNDA for venous thromboembolism in medically ill patients | Approved |
Nplate | Amgen | sBLA for pts with ITP for 12 months or less | Approved |
Ultomiris | Alexion Pharmaceuticals | sBLA for atypical haemolytic uremic syndrome | Approved |
Stelara | Johnson & Johnson | sBLA for moderate-to-severe ulcerative colitis | Approved |
Baxdela | Melinta Therapeutics | sNDA/BLA for community acquired bacterial pneumonia | Approved |
Zejula | Glaxosmithkline | sNDA for fourth-line ovarian cancer with BRCA mutations or homologous recombination deficiency | Approved |
Belviq/Belviq XR | Eisai | sNDA for cardiovascular outcomes data | No decision yet |
PF-06410293 | Pfizer | Biosimilar Humira; FDA accepted filing in Jan 2019 | No decision yet |
Fluzone Quadrivalent | Sanofi | sBLA for influenza vaccine – high dose | No decision yet |
Xtandi | Pfizer/Astellas Pharma | sNDA for metastatic hormone-sensitive prostate cancer | No decision yet |
Fasenra pen* | Astrazeneca | sBLA for pre-filled, single-use auto-injector in severe eosinophilic asthma | Approved |
TX01* | Tanvex Biopharma | Biosimilar Neupogen | CRL |
Xofluza* | Roche | sNDA for influenza in people 12 years of age and older who are at high risk of developing flu-related complications | Approved |
Botox* | Allergan | sBLA for paediatric lower limb spasticity | Approved |
Farxiga* | Astrazeneca | sNDA to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease | Approved |
Liletta* | Allergan/Medicines360 | sNDA to extend the duration of use for the prevention of pregnancy for up to six years | Approved |
*Not in September story. Source: Go or no go? Novartis eyes a big new growth driver, September 27, 2019. |