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Wednesday 19 June 2019
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Topic: phase iii

March 7, 2018
Danish pharmaceutical company Novo Nordisk’s diabetes drug, semaglutide, which could also be used to treat obesity, has passed its first Phase III clinical trial. Semaglutide is taken once daily as a tablet and works by increasing insulin production

As rates of diabetes continue to rise, the hunt for new drugs to tackle the metabolic disease is imperative. In 2014 there were an estimated 422 million people with diabetes, compared to just 108 million in 1980.

Although there are a range of treatment options available for type 2 diabetes, many target the symptoms rather than the root cause and may have adverse side effects. A further difficulty is the close connection between diabetes and obesity, which is causing cases to increase.

February 16, 2018
Nusinersen demonstrated stabilisation or improvement from baseline in motor function in individuals with 5q spinal muscular atrophy where the natural history of the disease is a decline in motor function over time

Biogen and Ionis Pharmaceuticals, Inc have announced end of study results from CHERISH, the Phase III study evaluating Spinraza® (nusinersen) for the treatment of individuals with later-onset 5q spinal muscular atrophy (SMA), were published in The New England Journal of Medicine.

The full manuscript titled, “Nusinersen Versus Sham Control in Later-Onset Spinal Muscular Atrophy,” appears in the 15 February 2018 issue of The New England Journal of Medicine.

February 9, 2018
Phase III SPARTAN data showed apalutamide improved median metastasis-free survival by over two years compared to placebo

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).

February 9, 2018
XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma

Amgen has announced results from the XGEVA® (denosumab) Phase III ‘482 study, the largest international multiple myeloma trial for the prevention of skeletal-related events ever conducted (n=1718), were published in The Lancet Oncology.

In this study, XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95% CI: 0.85-1.14).

February 1, 2018
The study showed that eslicarbazepine acetate monotherapy was non-inferior to twice-daily controlled-release carbamazepine, the current standard of care

Bial and Eisai have announced that leading clinical journal, Epilepsia, has published positive results from a pivotal Phase III monotherapy study of once-daily Zebinix® (eslicarbazepine acetate) in newly diagnosed focal epilepsy patients.1

November 30, 2017
Patients with episodic migraine taking erenumab reported significant and meaningful benefits over six months, with reduced migraine days and acute medication use

Novartis has announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase III STRIVE study evaluating erenumab in the prevention of episodic migraine (defined in STRIVE as 4 to 14 migraine days per month).1

November 16, 2017
Adult-onset Still’s disease and systemic juvenile idiopathic arthritis are rare systemic disorders of auto-inflammatory nature

Swedish Orphan Biovitrum AB has announced that the first patient has been randomised in the Phase III study anaSTILLs, to evaluate efficacy and safety of anakinra in the treatment of Still’s disease.

November 9, 2017
Tolvaptan reduced the rate of decline of kidney function by 35% over a 12-month period, compared to placebo, in patients with autosomal dominant polycystic kidney disease

Otsuka has announced detailed results from the Phase III REPRISE trial of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD).

September 18, 2017
More than 80% of patients receiving guselkumab, including patients transitioned from HUMIRA® (adalimumab) to the anti-interleukin (IL)-23 monoclonal antibody, demonstrated PASI 90 and IGA 0/1 scores at week 100

Janssen Research & Development has presented new longer-term data from the open-label extension of the VOYAGE 1 trial demonstrating consistent rates of skin clearance with guselkumab treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody.1

August 24, 2017
Kyprolis is the first and only multiple myeloma therapy proven to extend overall survival in a head-to-head comparison with a current standard of care in the relapsed setting

Amgen has announced that results from an overall survival (OS) analysis of the Phase III head-to-head ENDEAVOR trial were published online first in The Lancet Oncology.

June 15, 2017
Sirukumab Phase III data presented at the Annual European Congress of Rheumatology (EULAR) 2017 also show significant improvement in quality of life measures

Janssen-Cilag International NV has announced long-term results from SIRROUND-T, a pivotal Phase III study that showed sirukumab improved the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) through 52 weeks of treatment in adult patients with an inadequate response and/or intolerance to anti-tumour necrosis factor (TNF)-alpha treatments.1