US FDA approval tracker: October

Snippets

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.

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