UnaCom Product News Round Up

                                                     27th August-2nd September

NICE Rejects Gileads freshly EU approved Yescarta treatment due to draft guidelines

Gileads freshly approved CAR-T treatment has been rejected by NICE due to draft guidelines. The drug has just recently won approval from the EU, showing to be clinically effective against treating large B cell lymphoma. Along with Novartis's Kymriah, it is the first CAR-T treatment to be approved in this region. CAR-T treatment being a process by which 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. However NICE stated that there is no direct data to compare with the current treatment out there. Thus already providing a question mark over the benefits of Yescarta. NICE also stressed that its potential side effects 'will also need careful management'.  The committee also found Yescarta to be cost ineffective, with the cost-effectiveness estimates for Yescarta compared with salvage chemotherapy (the current treatment used)  were above £50,000 per year of quality adjusted life (QALY) gained, the upper limit of the specially extended range of cost effectives for cancer treatments, which means that the cost is “too high for it to be considered a cost-effective use of NHS resources”.

Marketing application submitted by Bayer for larotrectinib

A marketing application has been submitted in Europe for larotrectinib in the treatment of TRK fusion cancer.  This type of cancer leads to the production of TRK fusion proteins and leads to the development of tumour growth. The approval of the EU would lead to production of a targeted treatment options to those with no current treatment.

NICE changes decision on Ipsen's Cabometyx for kidney cancer 

In a Final Appraisal Determination, the cost watchdog came to the conclusion that the drug can be used as a first line treatment for adults with advanced renal cell carcinoma. NICE intially rejected Cabometyx in draft guidelines while admitting that clinical trial evidence does show that the drug does extend the period of time until cancer progresses compared with current treatment, the evidence on whether it boosts overall survial is less certain. Matthew Hickling , medical director of Ipsen UK said that "This reimbursement decision reflects the importance of our partnership with NICE who recognise that there are still limited treatment options available for people who have advanced RCC, a cancer which still has such a poor prognosis with a high unmet need."

First Treatment for rare lysosomal storage disoder cleared for use by EU

Ultragenyx' Mepsevii has been approved by the EU for use to treat lysosomal disorder, providing the very first approved treatment. The disorder results in the deficiency of an enzyme required for the breakdown of sulphates. The inability to break down these sulphates results in accumulation in the tissues and organs causing substanital damage. Mepsevii is an enzyme replacement therapywhich will prevent the accumulation of the sulphates in the tissue.

GSK's Nucala approved for young asthma patients

The European Commision has approved and granted the biological marketing authorisation for Nucala as an add on treatment for severe refractory eosinophillic asthma in patients from the ages of 6-17 years. Back in 2015, Nucala was approved as a treatment in adults based on the figures that showed it reduced the frequency of severe excaberations of asthma by 47%. compared to the placebo. According to the COLUMBA trial held, one third of people treated with Nucala experienced no excaberations despite coming into the trial experiencing an average of two excaberations per year. The trial also showed an 8% reduction in blood eosinophilis  (which causes inflammation in certain people with asthma.)

AstraZenecas 'Bydureon BCise device' approved by the EU 

The European Commision has approved AstraZenecas new formulation of its once weekly diabetes drug Bydureon. According to AstraZeneca it is a improved single dose, pre filled pen that requires no titration. It has been approved for use with other glucose lowering medicines.

NHS set for 'life changing' procedure for severe asthma patients

The treatment called Bronchial thermoplasty, akes place under sedation or general anaesthetic and involves delivering short pulses of radiofrequency energy to the airway wall to reduce the smooth muscle mass lining the airways, decreasing their ability to constrict. NICE has stated that this treatment can decrease the severity and frequency of severe asthma attacks, improving the quality of life of patients whose symptoms cannot be treated by drug therapy. Under this new data, the institute was able to change their recommondation from only using it for treatment for specific patients to being used on standard arrangements.

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