Sterling will begin shipments of its new inotropic agent, Inocor I.V. "by Aug. 20." The company announced FDA approval of the drug, its first major cardiovascular entry, on July 31. The direct price to hospitals and whslrs. is $16.25 per ampul; the ampuls, which contain a 20 ml solution with 100 mg of amrinone, are packaged in boxes of five. According to the FDA-approved labeling, "Inocor lactate injection is indicated for the short-term management of congestive heart failure." The indications' section further explains that "because of limited experience and potential for serious adverse effects . . . Inocor should be used only in patients who can be closely monitored and who have not responded adequately to digitalis, diuretics, and/or vasodilators." The section also notes that "although most patients have been studied hemodynamically for periods only up to 24 hours, some patients were studied for longer periods and demonstrated consistent hemodynamic and clinical effects. The duration of therapy should depend on patient responsiveness." FDA's approval of the drug comes almost two years after the agency's Cardio-Renal Drugs Advisory Cmte. recommended approval of the I.V. dosage form in October 1982. An NDA for the I.V. dosage form was filed in December 1981. FDA classified the drug as a 1B, signifying a new molecular entity with modest therapeutic gain. The package insert describes amrinone as representing "a new class of cardiac inotropic agents distinct from digitalis glycosides or catecholamines." While the drug's mechanism of action has not been fully determined, the labeling explains that, regarding amrinone's inotropic effect, "experimental evidence indicates that it is not a beta adrenergic agonist . . . Unlike digitalis it does not inhibit sodium-potassium adenosine triphosphatase activity. With respect to its vasodilatory activity, Inocor reduces afterload and preload by its direct relaxant effect on vascular smooth muscle." The adverse reactions section of the labeling notes that Inocor I.V. "resulted in platelet count reductions to below 100,000/mm or normal limits in 2.4% of the patients." The labeling adds that platelet reduction "is more common in patients receiving prolonged therapy" and is dose dependent. Cardiovascular adverse reactions include arrhythmia (3%) and hypotension (1.3%). The labeling also notes that "hepatotoxicity has been observed in man following long term oral dosing and has been observed in a limited experience (0.2%), following I.V. administration of amrinone." In a press release announcing the approval, Sterling noted it is "actively pursuing other compounds for the longer-term management of congestive heart failure." The compound furthest along is milrinone, an amrinone analog, currently in Phase III clinicals. Sterling healted clinical studies on an oral dosage of amrinone due to a high incidence of gastrointestinal side-effects. Sterling reported that Inocor I.V. has been approved in more than 20 countries, including Canada, West Germany, the Philippines and Mexico.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.
The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
