Novartis AG NVS announced 5-year open-label treatment period (OLTP) data on migraine drug Aimovig.
The study is being conducted to evaluate its sustained efficacy and long-term safety in patients taking 70mg and 140mg. Patients initially received 70mg of Aimovig monthly in the OLTP. The dose was increased to 140mg for the patients enrolled under the study after approximately 2 years. Of the 250 patients who switched from Aimovig 70mg to 140mg, 221 patients (88%) completed the OLTP or remained on 140mg at 4.5 years.
The interim analysis at 4.5 years showed that 77% of the patients who were still on treatment experienced at least a 50% reduction in monthly migraine days (MMD) at the last month of assessment. In addition, 33% of patients who continued with the regimen achieved a 100% reduction while 56% achieved a 75% decrease in MMD.
This encouraging data strengthens Aimovig’s position as the most prescribed anti-CGRP with more than 250,000 patients recommended worldwide since its launch.
Aimovig is designed specifically to block the calcitonin gene-related peptide receptor (CRGP). Per Novartis, Aimovig is the first FDA and EMA-approved CGRP-targeted therapy for the prevention of migraine in adults. Novartis and Amgen AMGN co-commercialize the drug in the United States. While Amgen has the exclusive rights to commercialize the drug in Japan, Novartis has the exclusive commercialization rights in the rest of the world. Both companies were involved in a lawsuit regarding this agreement.
CRGP is a new class of drugs, designed to reduce the number of migraine attacks. Also, this category has fewer adverse reactions in clinical trials and lesser warnings plus precautions compared with other approved migraine therapeutics. Other drugs in this category are Teva’s TEVA Ajovy and Eli Lilly’s LLY Emgality.
Shares of Novartis have inched up 4.6% so far this year against the industry’s decrease of 0.5%.
Novartis is looking to transform its business with focus on key therapeutic areas considering the weakness in the generic business and separation of eye-care business.
Novartis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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