Regulatory Index News: 03/05/2018

Welcome to your Regulatory Index News update today. There is plenty to catch up on with a second US approval for Kymriah, positive data for Mavenclad and an acquisition. Read here to find out more.

Second US approval awarded for Novartis' Kymriah

Novartis’ CAR-T therapy, Kymriah, is set to add a second indication to their label after another FDA approval. The intravenous infusion is now approved for treatment of adult patients with relapsed or refractory large B-cell lymphoma including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma, when the patient has already had at least two lines of systemic therapy. This makes Kymriah the first-ever CAR-T therapy to be FDA approved in two non-Hodgkin lymphoma (NHL) and B-cell ALL indications. With limited treatment options DLBCL patients with relapse or unresponsiveness to initial treatment, this new approval is welcomed where the median life expectancy is 6 months. Please click here if you would like to read more from a PharmaTimes article.

Merck reports positive data for MS treatment, Mavenclad 

Merck have released new data for Mavenclad in The Multiple Sclerosis Journal where data suggests promising results in two subgroups of patients with highly active relapsing multiple sclerosis (MS). The patients were categorised into these subgroups from the CLARITY study where the first, a categorically high relapse activity (HRA), are patients with ≥2 relapses during the year prior to the study. The other category, HRA plus Disease Activity on Treatment (HRA+DAT), is for those with ≥1 relapse and ≥1 T1 Gadolinium-enhancing (Gd) or ≥9 T2 lesions during the year prior to study whilst taking other DMDs. The data showed that Mavenclad was better than or comparable to the CLARITY study where it reduced risk of 6-month EDSS progression by 82% versus placebo, compared to a 47% in the CLARITY study. To learn more about this study click here for a PharmaTimes article.

United Therapeutics to gain SteadyMed’ competing PAH drug with $216M acquisition

United Therapeutics are set to acquire SteadyMed, with upfront cash amounting to $4.46 per share as well as $2.63 per share in milestone payments for Trevyent. The acquisition is based on the drug-device combo of treprostinil, Trevyent, designed to treat pulmonary arterial hypertension (PAH), which was submitted for approval in 2017 but received a Refusal to File letter until further testing procedure information was provided. With SteadyMed announcing it reached the FDA’s requirement for clinical trials and resubmission was due before the end of 2018, United Therapeutics decided to acquire the asset rather than compete on the marketplace later. If you would like to read further into this, please click here for an article from BioPharmaDIVE.



Max Lymbery

Date Published

03rd May 2018

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