The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) perspective on cardiovascular Polypill: A multidimensional concept.

Content Provider	Semantic Scholar
Author	Mogielnicki, Mariusz Świeczkowski, Damian Bachorski, Witold Żuk, Grzegorz Gilis-Malinowska, Natasza Zarzeka, Aleksander Merks, Piotr Gruchala, Marcin Jaguszewski, Milosz
Copyright Year	2016
Abstract	Received: 10.09.2016 Accepted: 10.09.2016 European Medicines Agency (EMA) and Food and Drug Administration (FDA) have the most powerful contribution to the development of law registration and efficient implementation of Polypill (and variety formulations with might be defined as fixed dose combination [FDC]) into clinical practice. Fixed-dose combinations are the consequence of evolution in pharmaceutical technology [1, 2]. The first attempt of applying a FDC in human clinical settings has been observed since the 70s. According to World Health Organization (WHO) experts, FDC in the secondary prevention of cardiovascular events are strongly recommended. Accordingly, FDA and EMA highlighted the potential benefits for the patient from the use of FDC regarding its clinical efficacy, low cost of therapy, and improving the adherence [3, 4]. Current European guidelines on cardiovascular diseases (CVD) prevention also recommend using FDC, due to patient convenience [5]. Currently, there is still no uniform and accepted definition of a Polypill. The early concept of Polypill was developed from combination of 5–6 active pharmaceutical ingredients (APIs) to formulation containing acetylsalicylic acid (ASA), statin and one antihypertensive agent (ramipril), which is the first Polypill approved in several Latin American and European markets under the trade names Trinomia, Sincronium, or Iltria (Ferrer International, Spain) [6]. According to the Fuster-CNIC-Ferrer concept, Polypill is defined as an oral dosage form containing a low dose of ASA, statin, and at least one antihypertensive drug used in the prevention of cardiovascular events [7, 8]. According to WHO guidelines 2005 [9] for registration of FDC medicinal products, Polypill as FDC comprised of APIs of well-established use may be a subject of the three considered scenarios of the registration process, i.e. i) as a generic drug for existing FDC with established quality, safety, and efficacy; ii) as FDC of single entity products used together in a well-established therapeutic regime; iii) as FDC of APIs, which have not been previously used in combination to prevent CVD or a combination of well-established use, but in a different therapeutic regimen. Depending on the scenario, appropriate set of documentation in the registration process should be included; the most detailed documentation is required if Polypill is the subject of scenario III. In this case, an inclusion of rational justification of introducing it onto the market, estimating the benefits and risks of the proposed formulation and evaluation of safety and
Starting Page	515
Ending Page	517
Page Count	3
File Format	PDF HTM / HTML
DOI	10.5603/CJ.2016.0074
PubMed reference number	27723064
Journal	Medline
Volume Number	23
Issue Number	5
Alternate Webpage(s)	https://journals.viamedica.pl/cardiology_journal/article/download/CJ.2016.0074/36138
Alternate Webpage(s)	https://zakladdydaktyki.wum.edu.pl/sites/zakladdydaktyki.wum.edu.pl/files/cardiology_journal.pdf
Journal	Cardiology journal
Language	English
Access Restriction	Open
Content Type	Text
Resource Type	Article