Regulatory Index News: 13/04/2018

Take a read here for your Regulatory Index News update on two new US approvals and why a phase 3 trial was halted.

US approval for Novartis’ TSC-related treatment

Novartis’ Afinitor Disperz is now FDA approved as the first medicine to specifically treat tuberous sclerosis complex (TSC)-associated partial-onset seizures in patients aged two or older. TSC is a rare genetic disorder which affects up to one million people globally, where 85% of those are affected by epilepsy and uncontrolled seizures and 60% of those have become resistant to anti-epileptic drugs. This new drug, which acts as an mTOR pathway inhibitor, is hoped to help tackle the unmet need of patients here as it did in clinical trials. The trial showed Afinitor Disperz led to a statistically significant increase in median percentage reduction from baseline of seizure frequency (29.3% in low-exposure group) when compared to placebo (14.9%). If you would like to read more on this, please click here for a PharmaTimes article.

Pfizer halts Inlyta trial after post-surgery kidney cancer failure

Pfizer have been investigating Inlyta as an adjuvant therapy in a phase 3 trial (ATLAS) which enrolled 724 patients at high risk of renal cell carcinoma (RCC) following surgical removal of kidney. However unfortunately, they have recently released a statement that after a review and finding that Inlyta did not help extend disease-free survival compared to placebo, a data monitoring committee has recommended a shutdown of the study. This is bad news for Pfizer who were hoping to add an expansion to the slowly declining drug. Regardless of the findings, Pfizer will go ahead with planned combination trials testing Inlyta with their immunotherapy, Bavencio, against Sutent. Please click here for more from a BioPharmaDIVE article.

AI device to detect diabetes-related eye disease approved by FDA

The US regulators have awarded an approval allowing IDx LLC to market their artificial intelligence (AI) software device, IDx-DR, to detect a greater than mild level of diabetic eye disease known as diabetic retinopathy without the need for a clinician to interpret the images or results. This makes the device usable by health care providers which would not normally be involved with eye care such as primary care physicians which typically interact with diabetic patients more frequently. The approval was based on clinical data that IDx-DR could determine the presence of more than mild retinopathy 87.4% of the time and could detect when not more than the mild disease 89.5% of the time. Please click here if you would like to read further into this in an article from Reuters.



Max Lymbery

Date Published

13th April 2018

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