ABSTRACT
Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel drugs are often innovative products that serve unmet medical needs or otherwise help to advance patient care.Methods: FDA novel drug approvals were analysed from calendar year (CY) 2012 to 2016 on the basis of three criteria i.e., impact, access and predictability. Impact measured on the basis of: percentage of novel drug approvals (a) first in class (b) for rare diseases. Access measured on the basis of: percentage of novel drug approvals (a) first cycle approval (b) approval in the U.S. before other countries and (c) percentage of priority reviews. Predictability measured by: the percentage of novel drug approvals that met the PDUFA goal dates for the application review.Results: Total number of novel drugs approved from CY 2012 to 2016 was 176 (average 35 novel drugs/ year). Impact of novel drug approvals: 40% were first in class and 39% were for rare diseases. Access of novel drug approvals: 84% were first cycle approval, 60% were approval in US before other countries, 51% priority reviews among novel drug approvals. Predictability of novel drug approvals: 97% approvals able to meet PDUFA goal dates for application review.Conclusions: Novel drug approvals during CY 2012-2016 had a high quality which is very much evident by their high impact, good access and high predictability.
ABSTRACT
Background: Diabetes Mellitus is a chronic metabolic disorder, one of the major causes of morbidity, mortality and needs lifelong treatment. There are large numbers of oral anti-diabetic drugs available for the treatment of type 2 diabetes mellitus. There are numerous brands available for each of the individual oral anti-diabetic drug. Thus, a study was planned to find out cost variation among different brands of same active oral anti-diabetic drug.Methods: Cost of a particular drug being manufactured by different companies, in the same strength and dosage forms was obtained from the price list provided by the pharmaceutical companies in Current Index of Medical Specialities (CIMS) (October 2017- January 2018). The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and percentage variation in price was analyzed.Results: Percentage cost variation of the commonly used drugs found was seen highest with Sulfonylureas (Glimepiride - 562%) followed by Metformin (492%) which was followed by Pioglitazone (488%), DPP-4 inhibitor Teneligliptin (231%), α- glucosidase inhibitors (Voglibose 284%), Meglitinides (Repaglinide 0.5mg 154%) and lowest was seen with Repaglinide 2mg (15%).Conclusions: There is very wide cost variation among different brands of the same oral anti-diabetic drugs manufactured in India. The average percentage cost variation of different brands of the same oral anti diabetic drugs manufactured in India is very wide. The appraisal and management of marketing drugs should be directed toward maximizing the benefits of therapy and minimizing negative personal and economic consequences.
ABSTRACT
Background: The purpose of this study was to compare and evaluate the clinical efficacy of topically applied travoprost 0.004% eye drops versus brimonidine/timolol fixed combination eye drops in the management of primary open-angle glaucoma. Methods: In this prospective, randomized study, 65 patients received either travoprost eye drops once daily in the morning (n=33) or brimonidine/timolol fixed combination eye drops twice daily (n=32). Intra ocular pressure (IOP) was assessed at 2, 4, 8, and 12 weeks. The primary outcome measure was mean reduction in IOP. Results: The baseline mean IOP values were similar between two groups. Mean reduction of IOP in the right eye for brimonidine/timolol fixed combination group was 9±2.9 mmHg, whereas in the left eye it was 10.9±2.8 mmHg. In the travoprost group, the reduction in IOP of the right eye was 7.8±2.9 mmHg (p=0.0002) and 7.5±3.4 mmHg (p=0.0001) in the left eye. The mean reduction of IOP for the brimonidine/timolol group was 9.95 mmHg and for the travoprost group it was 7.6 mmHg (p<0.0001) in both the eyes. Conclusions: The fixed combination brimonidine/timolol twice daily demonstrated superior mean IOP lowering efficacy compared to travoprost 0.004% in patients with open-angle glaucoma.