UnaCom Product News Round Up

     3rd September- 9th September


Monday 3rd September

AstraZenecas Lupus Therapy fails to hit Phase Three targets  

AstraZenecas experiemental drug anifrolumab has failed to reach expected targets by the company. In the Phase Three TULIP trial, which tested on patients with moderate to severe systemic lupus erythematosus (SLE) , there was no statistically significant reduction in disease activity after twelve months. The company announced that a full evaluation of the data will be conducted once the data from TULIP two is released and the data from the first trail, will be discussed in a medical meeting.

Janssen secures EU approval for Darzalex

Darzalex is a drug used as a first line treatment for patients with multiple myeloma. This approval stems from the data from the Phase three ALCYONE trial, which showed that Darzalex cut the risk of disease progression or death by 50% in its patient population. It also significantly improved overall response rates compared to the current treatment used. Including more than doubling rates of stringent complete response and boosting complete response or better.

Tuesday 4th September

Sanofi's treatment for rare bleeding disorder approved by the EU

Sanofi's new drug Cablivi, has been authorised by the European Commission for treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP). The condition is a life-threatening, autoimmune-based blood clotting disorder characterised by extensive clot formation in small blood vessels throughout the body leading to low platelet count, destruction of red blood cells and organ damage. In the HERCULES study performed Cablivi along with the current standard of care ( daily plasma exchange) significantly reduced the time to platelet count response, aTTP-related death, and recurrence of aTTP, or at least one major thromboembolic event during study drug treatment.

Pfizer ends two of its Duchenne muscular dystrophy drug trials 

Pfizer ended its two clinical trials assessing domagrozumab for the treatment of Duchenne muscular dystrophy. The first trial involved a safety and efficacy study and the second trial was an open label extension study. The trial investigating the safety and efficacy failed to meet its primary efficacy endpoint of demonstrating a difference following one year of treatment. Pfizer are disappointed by the results but say that the data will contribute to a greater understanding of this disease and we will evaluate the total data set to see if there is a place for this medicine in muscular diseases.

Wednesday 5th Sepember

Novo Nordisk and Oxford Univeristy to work together with diabetes alliance and research lab

Novo and Oxford University, are to set to begin work on therapeutic targets for type two diabetes, with new research facitilies opening next week. The alliance between the two will begin on the 12th of September. The move follows the firm’s plans ,revealed in January last year, to invest £115 million over 10 years into a new research centre housed by the University of Oxford, marking a major boost for UK life sciences. Novo has been working with the University, to build laboratories and employ up to 100 employees.

NICE changes position for rare disease therapy Crysvita

NICE, is now approving NHS funding  to treat X-linked hypophosphataemia (XLH) in children and young people with growing bones in England and Wales. NICE initally rejected funding due to data being 'limited and uncertain.'  It also said that while Crysvita can prevent irreversible bone damage, the long-term consequences of disease progression ,which the drug may not affect, were uncertain. However NICE noted that Crysvita meets the criteria for applying a QALY, weight because of the number of additional QALYs gained compared with current treatments (estimated at around 15). Therefore Crysvita, is considered value for money.

Novartis and NHS strike up deal with ground breaking Kymriah  

Hosptials are gearing up towards providing the ground breaking CAR-T thereapy Kymriah, for children with advanced leukaiema, after a provision made by NHS England. This is the first commercial deal with Novartis in the EU for this treatment, just ten days after it recieved its marketing authority, making it one of the fastest funding approvals in the NHS 70 year history. Kymriah works by harnessing the patient’s own immune system to fight certain types of blood cancer. During the process, T cells are drawn from a patient's blood and reprogrammed in the lab to create T cells that are genetically coded to hunt the patient's cancer cells. The therapy showed in clinical trials an 83 percent overall remission rate in this patient population with limited treatment options and historically poor outcomes. Kymriah costs around £282,000 per patient at its full listand extremely complex to administer. As such, hospitals wishing to provide CAR-T therapy must complete an international accreditation process. In England, the first hospitals to undergo this process are in London, Manchester and Newcastle. Subject to obtaining accreditation, these hospitals could offer the first treatments in a matter of weeks, NHS England said.

Celltrion calls upon the NHS to increase use of biologics in Rheumatoid Arthritis 

Celltrion Healthcare wants the NHS to lower the threshold for starting biologics in patients in Rhematoid Arthritis, and to put measures in place to boost patient access to such treatment. Patients treated with biologics for RA in Europe varies, with France and Italy at 24% or higher but only 15% in the UK. This is because in the UK a patient must have a disease severity score of 5.1 before treatment can be initiated, compared to only 3.2 in other European countries, says Celltrion. Despite NICE acknowledging the effectiveness of biologicals in the treatment of RA, access to these therapies remains restricted in UK on grounds of cost-effectiveness. Celltrion points to using biosimilars, saying that switching patients to biosimilars of these biologics led to significant cost savings. Pointing to data that NHS England saved £324 million in the last financial year by switching from using 10 higher priced medicines to better value biosimilars and generic medicines which are considered to be equally effective and safe alternatives.  Mr HoUng Kim, head of strategy and Operations at Celltrion said: “Patients diagnosed with less than severe disease activity should be able to get just as good and cost-effective benefit from biologics as patients with severely active disease, as this will help them achieve a better quality of life”

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