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In a significant breakthrough for the pharmaceutical industry, two groundbreaking treatments have received approval in major markets. Skyrizi, an injectable antibody for the treatment of psoriasis, has been given the green light in the U.S., EU, and Japan, making it available in these markets. Developed by AbbVie, Skyrizi is currently being evaluated for additional indications such as Crohn's disease, ulcerative colitis, and psoriatic arthritis. The Cortellis Analytics™ - Drug Timeline & Success Rates (DTSR) tool forecasts Skyrizi with an 83% likelihood of approval in the U.S., EU, and Japan for the treatment of Crohn's disease, and a 90% chance in both the U.S. and Europe for psoriatic arthritis. Meanwhile, Zynteglo, a gene therapy for beta-thalassemia, has been granted EU approval and conditional approval in Japan. Zynteglo treats transfusion-dependent beta-thalassemia, a blood disorder that can cause life-threatening anemia and necessitate regular lifelong blood transfusions. In clinical trials, 15 of 19 patients achieved transfusion independence after Zynteglo treatment. The treatment was approved as part of the PRIME and Adaptive Pathway programs, and its review took just 150 days, the shortest time for an advanced therapy medicinal product by the EMA to date. The potential lifetime value of Zynteglo is over $2 million, similar to that of Zolgensma, a gene therapy for spinal muscular atrophy, which was launched in 2019 with a price tag of $2.125 million, or $425,000 annually over five years. Zolgensma, which requires only a single dose, is being evaluated for approval in Europe and Japan. bluebird bio, the manufacturer of Zynteglo, plans to file a BLA by the end of 2019 in the U.S. and expects the drug's price to be announced by mid-June, with analysts predicting prices of up to $1.2 million in the U.S. and $0.9 million in the EU. The manufacturer of Zolgensma, Novartis International AG through its subsidiary AveXis, received conditional marketing authorization in the European Union in June 2019. With these approvals, the future of personalized medicine continues to evolve, offering hope for patients suffering from these debilitating conditions. The option to spread payments over up to five years, with further outcomes-based models to be agreed upon, could make these life-changing treatments more accessible to a wider patient population.
