Regulatory Index News: 01/02/2018

Welcome to your first February Regulatory Index News digest. Read here for your important Pharmaceutical updates.

FDA approval for Novartis-acquired cancer drug Lutathera

Only a few months after Novartis acquired Advanced Accelerator Applications, the FDA have approved their first-in-class treatment of rare cancers in the digestive tract known as somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera is the first US approved peptide receptor radionuclide therapy (PRRT) where it works by binding to the receptors and then uses radiation to fight the cancer. GEP-NETs are diagnosed in around 1 in 27,000 people in the US and is known to have very limited treatment options after initial therapy fails to keep the cancer from growing. This leaves the approval a great step forward in the therapeutic area with predicted sales to be around $500m-$1b at its peak. If you would like to read more, please click here for an article from FiercePharma.

Aradigm’s Linhaliq rejected by FDA with request for further Phase 3 study

The FDA have rejected Aradigm’s inhaled version of the ciprofloxacin antibiotic with a Complete Response Letter (CRL) requesting further Phase 3 study. This was not unexpected after an advisory panel had opposed approval of Linhaliq in January to treat a type of chronic lung infection. This is down to the mixed Phase 3 findings of two studies where one (ORBIT-4) showed that Linhaliq significantly lengthened median time to the first pulmonary exacerbation while the other (ORBIT-3) whilst showing numerical advantage, was not statistically significant. This poses a further cost to the California-based biotech which saw a 20% fall in share price on Monday and a 75% drop since a peak in December. Aradigm however continues in planning to submit an application to the EMA. Please click here for a BioPharmaDIVE article to read further.

Roche’s autism drug awarded breakthrough status

Balovaptan, a vasopressin 1a (V1a) receptor antagonist, has recently received a breakthrough status designation by the FDA for its potential treatment of people with autism spectrum disorder (ASD). Clinical trial evidence has implicated the V1a receptor in modulating several key social behaviors which are challenging for those with ASD such as repetitive behaviors, restrictive interests and communication issues. There is estimated to be a global prevalence of ASD at 1 in 160 people and there are currently no pharmacological treatments to target this receptor, which shows the potential of this treatment. This breakthrough status may now allow for an accelerated development and regulatory review, leading to a faster path to market. Please click here to read more from a PharmaTimes article.



Max Lymbery

Date Published

01st February 2018

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