Merck & Co., Inc. (MRK) Receives FDA Approval For ISENTRESS® (raltegravir) For Pediatric Oral Suspension
1/8/2014 7:24:31 AM
Merck Receives FDA Approval for ISENTRESS® (raltegravir) for Pediatric Oral Suspension
WHITEHOUSE STATION, N.J.-- Merck (MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) recently approved ISENTRESS® for oral suspension, a new pediatric formulation of Merck’s integrase inhibitor. With this approval, ISENTRESS is now indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients four weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response. The oral suspension may be used in patients as young as four weeks of age, weighing at least 3 kg to less than 20 kg. The safety and efficacy of ISENTRESS have not been established in infants less than four weeks of age. Formulations of ISENTRESS for specific populations now include oral suspension, chewable tablets and film-coated tablets.
“We are very pleased that ISENTRESS can now be a part of a treatment regimen for HIV-1 infected infants and children as young as four weeks of age,” said Hedy Teppler, executive director, Clinical Research, Merck Research Laboratories.
Merck anticipates that the oral suspension formulation will be available in the United States during the third quarter of 2014.
Important Selected Safety Information
ISENTRESS does not cure HIV-1 infection or AIDS.
Severe, potentially life-threatening and fatal skin reactions have been reported.This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis.Immediately discontinue treatment with ISENTRESS (raltegravir) and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develop and monitor clinical status, including liver aminotransferases closely.
Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.
ISENTRESS chewable tablets contain phenylalanine, a component of aspartame, which may be harmful to patients with phenylketonuria.
Co-administration of ISENTRESS with drugs that are strong inducers of uridine diphosphate glucuronosyltransferase (UGT1A1) may result in reduced plasma concentrations of raltegravir. Co-administration of ISENTRESS and other drugs may alter the plasma concentration of raltegravir. The potential for drug-drug interactions (DDIs) must be considered prior to and during therapy. Co-administration or staggered administration (by 2 hours) of aluminum and/or magnesium hydroxide-containing antacids and ISENTRESS is not recommended. Rifampin, a strong inducer of UGT1A1, reduces plasma concentrations of ISENTRESS. Therefore, the dose of ISENTRESS for adults should be increased to 800 mg twice daily during coadministration with rifampin. There are no data to guide co-administration of ISENTRESS with rifampin in patients below 18 years of age.
The most commonly reported (=2%) drug-related clinical adverse reactions of moderate to severe intensity in treatment-naïve adult patients receiving ISENTRESS compared with efavirenz were insomnia (4% vs 4%), headache (4% vs 5%), nausea (3% vs 4%), fatigue (2% vs 3%) and dizziness (2% vs 6%), respectively. In treatment-experienced adult patients receiving ISENTRESS, the most commonly reported (=2% in either treatment group) drug-related clinical adverse reactions of moderate to severe intensity and at a higher incidence compared with placebo was headache (2% vs 1%). Intensities were defined as follows: Moderate (discomfort enough to cause interference with usual activity); or Severe (incapacitating with inability to work or do usual activity).In treatment-experienced children and adolescents four weeks through 18 years of age receiving ISENTRESS, the frequency, type and severity of drug-related adverse reactions were comparable to those observed in adults.
Grade 2 to 4 creatine kinase laboratory abnormalities were observed in patients treated with ISENTRESS. Myopathy and rhabdomyolysis have been reported. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions and patients with a history of rhabdomyolysis, myopathy or increased serum creatine kinase.
Rash occurred more commonly in treatment-experienced subjects receiving regimens containing ISENTRESS (raltegravir) plus darunavir/ritonavir, compared to subjects receiving ISENTRESS without darunavir/ritonavir or darunavir/ritonavir without ISENTRESS. However, rash that was considered drug-related occurred at similar rates for all three groups. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash.
ISENTRESS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.To monitor maternal-fetal outcomes of pregnant patients exposed to ISENTRESS, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.
ISENTRESS is Merck's integrase inhibitor for the treatment of HIV-1 infection in adult and pediatric patients ages four weeks and older and weighing at least 3 kg as part of combination HIV therapy. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity.Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells. ISENTRESS is now approved as part of combination therapy in more than 76 countries for use in treatment-naïve adult patients with HIV-1 and in more than 114 countries for use in treatment-experienced adult patients with HIV-1. ISENTRESS, in combination therapy, for use in children and adolescents with HIV-1 ages two years and older has also been approved for use in 35 countries. Merck is continuing to move forward with filings of ISENTRESS for oral suspension in additional countries around the world.
To assist patients taking ISENTRESS, Merck offers the SUPPORT™ program, which provides personal support and patient advocacy regarding individual reimbursement issues. For more information about the SUPPORT™ program, please visit www.merckhelps.com or call 1-800-850-3430.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2012 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for ISENTRESS (raltegravir) at http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_pi.pdf and Patient Information for ISENTRESS at http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_ppi.pdf.
ISENTRESS® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., USA
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