Correvio Pharma Corp. (NASDAQ:CORV) has had an exciting year for Brinavess so far in 2018. The asset was initially developed by Correvio’s predecessor company Cardiome starting in 1986 and bought by Merck for further development after completing Phase III studies in 2009. While it received EMA regulatory approval in 2010, it was not given the go ahead in the United States and has been on hold with the FDA ever since.
Despite the hold, things have begun to turn in favor of Brinavess on several fronts. Chinese partner Eddingpharm began enrolling in a Phase III trial in May and the Chinese FDA identified the drug as clinically urgently needed. Separately, Brinavess was identified as potentially eligible for priority review in China, which could lead to faster approval in the country. Journal articles on the atrial fibrillation drug were given awards in Europe and a Belgian study found that normal heart rhythm was restored in 85% of patients, building confidence and acceptance of the drug and reimbursement approval in the country.
In parallel with these events, the Phase IV post approval study in Europe announced that it had completed over 2,000 treatment events in April, and reported preliminary data earlier this month.
There was also advancement in the US with the FDA allowing for a pre-NDA meeting and resubmission of the NDA, which is expected to occur early next year. Management is currently preparing for the meeting and could potentially use data from electronic health records obtained in ex-US use of the drug in support of approval. In a favorable scenario, Correvio could be in a position to resubmit the NDA in 2Q:19 and receive an FDA response by 4Q:19, following a six month review. A substantial amount of post-approval work that has been done worldwide including the recently completed SPECTRUM study, which may be used in support of favorable action by the FDA. An estimated 40 thousand patients in 42 countries have been administered Brinavess, which provides a substantial data set for the agency’s consideration.
The preliminary data from the SPECTRUM post-post approval study was released on September 5th. The study examined 1,778 unique patients, who experienced 2,009 treatment episodes and was launched in 2011. 53 different hospitals in the EU contributed to the effort.
Treatment with Brinavess converted over 70% of patients within a median of 11 minutes after infusion began. Safety was relatively favorable with only 28 serious adverse events (1.4%) reported in 26 patients. Other adverse events included significant hypotension, ventricular arrhythmia, atrial flutter or bradycardia reported for 17 patients.
The fast action in the vast majority of patients is a favorable outcome that will likely help make the case for advancement in the United States with the FDA. With about 2 million initial detected atrial fibrillation episodes, a large market for Brinavess exists. We feel that with the confidence inspired by FDA approval, this fast acting and inexpensive drug can take substantial market share as it advances past upcoming milestones towards approval in world’s most two largest economies.
Below, we highlight Correvio’s most recent timeline and milestones for Brinavess and other products in their portfolio. The timeline hypothesizes a 2020 launch of the drug in the US if the company can achieve a 2H:19 NDA submission.
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