UnaCom Product News Round Up

                                     Monday 20th August- Sunday 26th August


NICE Rejects Europes first allogeneic stem cell therapy treatment

NHS cost regulators for England and Wales have rejected funding for TiGenix and Takedas Alofisel, the first allogeneic stem cell therapy to be approved for use across the European Union for use in Crohns disease. In clinial trials of the drug it showed a 44 percent greater probability of acheiving combined remission compared to the placebo. In draft guidlines, NICE said that Alofisel only showed a  modest improvement in the patients tested. It aslo stated that reliable follow up results were only avaliable for one year, so its unclear how long the benefits will last. This balanced with uncertain cost estimates resulted in the committee not able to approve funding. Takeda has announced in a statement that it is "fully committed to collaborating with the IBD community, NICE and NHS England to identify any relevant data which may help to answer the questions raised in NICE’s draft guidance and allow them to make a positive recommendation".

Pfizers Lorlatinib designated a Promising Innovative Medicine  

Lorlatinib has been approved as a Promising Innovative Medicine for non small cell lung cancer.  The PIM award shows that regulators consider it a potenital candidate for the UKs Early Access scheme,which gives patients with life threatening or seriously debilitating conditions access to medicines before they are approved for use in Europe. In the next stage of the approval process, the Agency will issue an EAMS Scientific Opinion if the quality, safety and efficacy data provided in support of the application is sufficient to support a positive benefit/risk balance and added clinical value, paving the way for patient access, opening up access before a regulatory decision is reached.

Mixed Results for AstraZenecas Bevepsi AeroSphere 

AstraZeneca are pondering over the results of their phase three trial Bevepsi AeroSphere in patients with moderate pulmonary disease. In the trial it showed non inferiority to the current treatment out their created by GSK ( Anoro Ellipta). Head of Global Medicines Development said that the perfomance of Bevepsi AeroSphere is inconsistent with previous results and further analysis will be taken to understand and characterise these findings.

NICE clears the use of Steam Therapy for benign enlarged prostate 

A green light from NICE has allowed for men with benign prostatic hyperplasia to recieve a procedure called transurethral water vapour ablation on the NHS. The NHS watchdog has approved this treatment which involves using a needle to be inserted into the prostate to deliver steam to kill of excess cells and reduce the size of the prostate. This treatment can be seen to improve lower urinary tract symptoms, one to three months after treatment without impairing sexual function.


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