Novo Nordisk to launch Ryzodeg� insulin April 24
drugs.com
Danish pharmaceutical giant Novo Nordisk launched Ryzodeg for type 2 diabetic patients in Bangladesh on April 24, 2015
with a view to providing first in its class treatment through ensuring safety and flexibility in taking
injection.
Ryzodeg is a simple regimen with fewer injections than basal-bolus therapy that provides successful reduction of blood glucose with less chances of hypoglycaemia compared to conventional insulins, said A Rajan Kumar, managing director Novo Nordisk Pharma (Pvt.) Ltd.
People with diabetes currently using basal-bolus regimens may need to take up to four daily injections, which can be inconvenient and stressful. Ryzodeg
requires only two injections daily, Rajan said.
Novo Nordisk, the global leader in diabetes care, has always been striving to develop products that address key challenges faced by people with diabetes and physicians, he said.
Ryzodeg is a combination of two distinct insulin analogues, degludec and aspart with ratio of 70:30, making it the first true combination of a basal insulin with an ultra-long duration of action and a well-established mealtime insulin in one pen.
For more than 90 years, Novo Nordisk has been leading the fight against diabetes by developing the most innovative products based on patient needs, he said.
We are serving Bangladesh with world class insulins for more than 50 years.
In a country like Bangladesh where diabetes has become one of the biggest healthcare challenges, it is critical that product innovations are aimed at assisting physicians to provide better and effective treatment options, he said.
Ryzodeg is an innovative product that will give the healthcare professional a better way to manage the condition, Kumar said.
Ryzodeg is a new approach to diabetes management, and we are very pleased to make it
available now for people with diabetes in Bangladesh, said Dr. Mohammad Saiful, head of
marketing Novo Nordisk Pharma (Pvt.) Ltd.
Ryzodeg has documented excellent glucose control and a low risk of hypoglycaemia in clinical trials, and it represents an excellent opportunity for intensification of insulin treatment with fewer injections than other treatment options, Saiful said.
Key Features of Ryzodeg
In a multinational trial, Ryzodeg (insulin degludec/insulin aspart) delivered twice daily at main meals offered a successful reduction in HbA1c1,3 with lower risk of hypoglycaemia versus biphasic insulin aspart 30 in people with type 2 diabetes, showing:
32% lower risk of overall confirmed hypoglycaemia
73% lower risk of nocturnal confirmed hypoglycaemia
In other studies no apparent differences were shown between Ryzodeg and its comparators, with respect to adverse events and standard safety parameters.
Its an excellent drug and provides efficacy by:
A simple regimen with fewer injections than basal and bolus therapy
Successful reductions in HbA1c30
Lower risk of overall and nocturnal hypoglycaemia vs BIAsp 30
About the clinical trial
programme
The clinical trial programmes for insulin degludec (BEGIN) and Ryzodeg (BOOST) comprise the largest in the field of insulin therapy, including more than 11,000 people. Novo Nordisk completed the phase 3a BOOST programme in 2010.
This programme consisted of six randomised, controlled, treat-to-target trials in more than 30 countries. More than 2000 people were included in the development programme. The programme was designed after consultancy with regulatory agencies in Europe, Japan and USA. n
Stethoscope Desk
Prophylaxis and treatment of Malaria with Malarone (Atovaquone and Proguanil Hydrochloride)
Malarone is indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.
Malarone is indicated for the treatment of acute, uncomplicated P. falciparum malaria. Malarone has been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.
Contraindications
Hypersensitivity
Malarone is contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or Stevens-Johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation.
Severe Renal Impairment
Malarone is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance 30 mL/min) because of pancytopenia in patients with severe renal impairment treated with proguanil.
Warnings and Precautions
Vomiting and Diarrhea
Absorption of atovaquone may be reduced in patients with diarrhea or vomiting. If Malarone is used in patients who are vomiting, parasitemia should be closely monitored and the use of an antiemetic considered.
Vomiting occurred in up to 19% of pediatric patients given treatment doses of Malarone. In the controlled clinical trials, 15.3% of adults received an antiemetic when they received atovaquone/proguanil and 98.3% of these patients were successfully treated. In patients with severe or persistent diarrhea or vomiting, alternative antimalarial therapy may be required.
Relapse of Infection
In mixed P. falciparum and Plasmodium vivax infections, P. vivax parasite relapse occurred commonly when patients were treated with Malarone alone.
In the event of recrudescent P. falciparum infections after treatment with Malarone or failure of chemoprophylaxis with Malarone, patients should be treated with a different blood schizonticide.
Hepatotoxicity
Elevated liver laboratory tests and cases of hepatitis and hepatic failure requiring liver transplantation have been reported with prophylactic use of Malarone.
Severe or Complicated Malaria
Malarone has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria, including hyperparasitemia, pulmonary edema, or renal failure. Patients with severe malaria are not candidates for oral therapy.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Because Malarone contains atovaquone and proguanil hydrochloride, the type and severity of adverse reactions associated with each of the compounds may be expected.
The lower prophylactic doses of Malarone were better tolerated than the higher treatment doses.
Prophylaxis of P. falciparum Malaria: In 3 clinical trials (2 of which were placebo controlled) 381 adults (mean age 31 years) received Malarone for the prophylaxis of malaria; the majority of adults were black (90%) and 79% were male.
In a clinical trial for the prophylaxis of malaria, 125 pediatric patients (mean age 9 years) received Malarone; all subjects were black and 52% were male. Adverse experiences reported in adults and pediatric patients, considered attributable to therapy, occurred in similar proportions of subjects receiving Malarone or placebo in all studies.
Prophylaxis with Malarone was discontinued prematurely due to a treatment related adverse experience in 3 of 381 (0.8%) adults and 0 of 125 pediatric patients.
Source: drugs.com
