K.O.！ Novartis multiple sclerosis drug Gilenya's first head-to-head Phase III study beats Teva's super-heavy product Co.

Swiss pharmaceutical giant Novartis recently released data on the top line of ASSESS in its phase IIIb study of the oral drug Gilenya (Fingolimod) for multiple sclerosis (MS). This was a randomized, head-to-head, review-and-drug blindness study conducted in patients with relapsed remission-relieving multiple sclerosis (RRMS) that assessed the efficacy and safety of two doses of Gilenya (0.25 mg, 0.5 mg, oral once daily) over a one-year period compared to the tyva injection product Copaxone (acetic acid gratide, 20 mg daily subsulphic injection). Novart launched the study in 2012 as part of a FDA-approved post-market commitment, with 1,064 patients included, including 352, 370, 342 randomly entered the Gilenya 0.5mg, Gilenya 0.25mg, Copaxone 20mg treatment queue.
data show that Gilenya 0.5mg significantly reduced the annual recurrence rate (ARR) by 40.7% over the one-year treatment period (ARR valuation: 0.153 vs 0258, p=0.0138). Further preliminary results showed that the Gilenya 0.25 mg treatment group had a reduced risk of recurrence compared to the Copaxone treatment group, but was not statistically significant. In terms of safety, the safety of the two doses of Gilenya and Copaxone in the study was consistent with the known drug safety profile, and the Copaxone treatment group had higher overall drug suspension rates due to adverse reactions and dissatisfaction with the effectiveness of the treatment.is the first head-to-head study to evaluate the superior efficacy of an MS disease modification therapy over Copaxone in reducing recurrence, which is a key indicator of disease activity and an important indicator of patient burden, said lead researcher of the
ASSESS study and Professor Bruce Cree of the University of California, San Francisco. Such head-to-head studies are essential to help clinicians better understand the relative efficacy and safety of MS therapy and thus make more informed treatment decisions. Danny Bar-Zohar, Head of Global Neuroscience Development at Novarma Pharmaceuticals, said Gilenya, as the first oral MS drug to redefine the clinical care of MS, added strong evidence from ASESS that Gilenya is an efficient, cornerstone therapy for relapsed MS.
Gilenya is a neuroaminol 1-phosphate-subject regulator that was originally approved by the FDA in 2010 to treat adult patients with relapsed MS and approved in May 2018 for children and adolescents 10 years of age and older with relapsed MS. Gilenya is the first oral disease modification therapy for MS treatment, with a reversible redrawing of lymphocytes for lesions and diffuse central nervous system (CNS) damage caused by MS. In patients aged 10 years and older with relapsed MS, Gilenya 0.5 mg showed high efficacy across multiple disease activity evaluation indicators. Long-term treatment experience has shown that Gilenya can easily integrate into a patient's daily life, resulting in high treatment satisfaction and long-term compliance, and ultimately improving the patient's long-term prognostication. To date, Gilenya 0.5mg has been used in the treatment of more than 255,000 patients.
Copaxone, a super-heavy product of Teva, was launched in 1996 as the world's best-selling MS drug, with sales of $4.24 billion in 2014 and the patent expiring in September 2015. Teva received regulatory approval for the long-acting version of Copaxone (three injections per week) in January 2014 and has since successfully switched patients to the long-acting version of Copaxone, which is critical to Teva's successful launch in major markets around the world and has become an important bargaining chip for Teva to defend its MS franchise. But Copaxone's market share has been shrinking due to the impact of generics and the launch of the new bioMS competition. In 2017, for the first time, sales of the oral drug Tecfidera ($4.2 billion) surpassed Copaxone ($3.8 billion) as the best-selling drug on the MS market.
In fact, Teva has also long been in place for oral MS drugs, and in 2004 the company licensed an oral small molecule, laquinimod, from Active Biotech, a CNS-activated immunomodulant that can pass through the blood-brain barrier and act directly on CNS inflammation and neurodegenerative lesions. The drug has been positioned as Copaxone's successor for development over the years, but progress has been slow over the past 14 years and has been rejected several times by regulators because of its potentially carcinogenic and excessive side effects on pregnant women, as well as its relapse in MS patients, although Teva has organized a third large-scale Phase III study, which was eventually terminated due to heart side effects.
, in early September, Teva tearfully returned Laquinimod to Active Biotech, a blow to Teva, which has faced frequent research and development difficulties in recent years. As a generic drug giant, Teva's own overweight pound MS brand drugs now face generic drugs, oral MS drugs, new MS biopharmaceuticals, while the failure of new drug research and development is difficult to have successor products, as a witness to the brilliant achievements of Teva MS small editor, in the face of this situation, can not help but sad from the heart, the former MS giant really want to go away! (Bio Valley)