Regulatory Index News: 20/03/2018

Welcome to your Regulatory Index News update today. Read here to learn of a new US approval, acquisition and NICE recommendation.

US approval for CSL Behring’s Hizentra

Just one day after CSL Behring’s Hizentra was approved in Europe, the new rare disease drug has also been awarded its FDA approval. The drug is to be used as a maintenance therapy for a rare autoimmune disease known as chronic inflammatory demyelinating polyneuropathy (CIDP) or Vidaurri’s disease, which causes symptoms such as numbing, tingling and pain. Hizentra is administered as a subcutaneous immunoglobulin and can be used at home, rather than requiring patients to visit a hospital as with the standard intravenous immunoglobulin (IVig) treatment. The approval was based upon positive phase 3 trial data (PATH) which showed statistically significant lower relapses or withdrawals in patients when compared to placebo, at 38.6% for low-dose Hizentra to 63.2% on placebo. Patients in the trial also reported fewer adverse events when compared to IVIg treatment. If you would like to read more, please click here for an Endpoints article.

Lundbeck to buy Parkinson’s drug developer

Lundbeck is set to buy Prexton Therapeutics for its phase 2 Parkinson’s drug candidate. The takeover will give Lundbeck control of a mGluR4 positive allosteric modulator known as Foliglurax, designed to improve long-term symptom control of dopaminergic agents. Foliglurax is Prexton’s only pipeline drug, which has proceeded into phase 2 with the belief that it can control Parkinson’s symptoms better than just targeting dopaminergic pathways as seen with other drugs. The purchase will include €100 million upfront from Lundbeck with milestone payments up to €805 million depending on its clinical, regulatory and commercial success. Whilst a promising drug candidate, top-line results are 12 months away where Prexton has relied majorly on primate data to make its case to investors and acquirers. Please click here to read further from a FierceBiotech article.

NICE approval for Keytruda in bladder cancer

NICE has recommended MSD’s Keytruda as the first ever immunotherapy on the NHS, via the Cancer Drugs Fund, to treat urothelial carcinoma (locally advanced or metastatic) when prior platinum-containing chemotherapy fails. The institute was leading to a rejection for the drug in this setting due to its cost effectiveness, however after consultation, they determined Keytruda provided an important extension-to-life benefit when compared to standard of care. This comes as great news to many UK residents, with over 10,000 a year being diagnosed with bladder cancer and around a possible 540 of which could benefit from Keytruda. Please click here if you would like to read more from a PharmaTimes article.



Max Lymbery

Date Published

20th March 2018

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