The FDA pushes the decision for the cytokinetic cardiac drug to examine the proposed safety plan
Cytokinetics aims to compete with a cardiac medication Bristol Myers Squibb projected to become a successful seller, and the company’s value proposal is that its drug candidate has a potential safety advantage. Biotechnology must wait a little longer to see what FDA thinks.
The agency postponed the target date of September for a regulatory decision to examine a security plan proposed for the drug, AFICAMTEN, announced the closure of the market on Thursday. The new decision -making date is December 26.
AFICAMTEN is being examined as treatment of obstructive hypertrophic cardiomyopathy, a disorder in which the heart muscle becomes abnormally thick, which makes it more difficult for the heart to pump blood. Cytokinetics medication is a small molecule designed to inhibit mutated versions of a heart muscle protein that leads to this thickening.
BMS Drug Camzyos was the first in this class of myosine inhibitory drugs. Its approval from the FDA in 2022 introduced an alternative to older heart medication which offered limited efficiency. BMS said $ 602 million in Camzyos in 2024, compared to $ 231 million the previous year.
The Camzyos label offers a black box warning for the risk of complications such as heart failure. This drug is only available in a risk assessment and mitigation strategy (REMS). For drugs that include serious safety risks, a REMS informs prescribers and patients on the risk and sets up a surveillance or managing framework.
The results of phase 3 for cytokinetic medication showed an adverse event profile similar to a placebo and no case of reported heart failure. The request to seek FDA approval contained “an approach to attenuation of distinct risks specific to AFICAMTEN”, according to the annual Cyotkinetics report. But this approach was not a formal rem.
“We believe that AFICAMten’s commercial prospects are strongly dependent on the question of whether the FDA approves AFICAMTEN with a label and / or post-commercialization conditions which are less difficult for prescribers and patients than the APR-applicable to Camzyos,” said company in the report.
In its announcement Thursday, Cytokinetics said that during the AFICAMten exam, the FDA asked the company to submit a “REMS” based on the inherent characteristics of AFICAMTEN “. The company respected the request. However, the agency considers that this additional information is a major amendment at the request of the drug. The main amendments trigger an extension of three months of the examination of a medication.
Cytokinetics said the FDA had not requested clinical data or additional studies. In a prepared statement, the president and chief executive officer of cytokinetics, Robert Blum, said that the company “remains confident in the distinct profile of the risk of services and the pharmaceutics of Aficamen and continue to expect a differentiated label and a profile of attenuation of the risks during his potential approval by the FDA.”
In a note sent to investors, Leerink Partners’ analyst Roanna Ruiz said that FDA’s request for an REMS after AFICAMTEN’s initial submission could indicate that the agency re -evaluates its approach to manage the risks for the broader class of myosine inhibitors. On an optimistic note, she added that the delay could give more time to cytokinetics to negotiate with the FDA A Rems differentiated from that of the BMS medication. But she added that this development raises several questions, such as what prompted the FDA to request a security plan after accepting the initial deposit without one.
“Despite this uncertainty, we remain constructive that this may be a procedural delay which does not fundamentally modify the prospects for approval for AFI[camten]Although there is a little more uncertainty about what the end of AFI could look like, “said Ruiz.
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