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FDA Approves Sustiva for Use in Pediatric Patients with HIV

Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of Sustiva (efavirenz) in HIV-1 Infected Pediatric Patients

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg. This approval offers a once-daily option as part of a regimen for this population and includes a “capsule sprinkle” administration method for patients who cannot swallow capsules or tablets. Detailed information about the “capsule sprinkle” method is provided in the ‘Instructions for Use’ at the end of the Patient Information section of the Package Insert.

Sustiva is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was originally approved in the U.S. in 1998 to treat HIV-1 infected children three years of age or older and weighing at least 10 kg. Sustiva is not to be taken by patients who are allergic to efavirenz, or to any of its ingredients.

“Bristol-Myers Squibb recognizes the importance of offering alternative methods of administration of HIV medicines, including for pediatric patients who cannot swallow tablets or capsules, and their caregivers who help manage their treatment,” said Brian Daniels, M.D., Senior Vice President, Global Development and Medical Affairs. “This approval is one example of our enduring commitment to the HIV patient community.”

This sNDA was based on results from three open-label studies that evaluated the pharmacokinetics, safety, and antiretroviral activity of Sustiva in combination with other antiretroviral agents in 182 antiretroviral-naïve and –experienced HIV-1 infected pediatric patients (three months to 21 years of age) for a median of 123 weeks. Virologic and immunologic response was observed across all ages at the end of the studies, as measured by HIV RNA and CD4 cell count.

The adverse reactions observed in the three pediatric trials were similar to those observed in clinical trials in adults, except that rash was more common in pediatric patients (32 percent for all grades regardless of causality) and more often of higher grade (i.e., more severe). Five pediatric patients (2.7 percent) discontinued from the study because of rash. Use of Sustiva (efavirenz) in patients younger than three months of age OR less than 3.5 kg body weight is not recommended because the safety, pharmacokinetics and antiretroviral activity of Sustiva have not been evaluated in this age group and there is a risk of developing HIV resistance if Sustiva is underdosed.

Bristol-Myers Squibb remains at the forefront of HIV/AIDS research and continues to pursue the development of treatment options for children and adults with HIV. Studies are ongoing for new treatments, including an NRTI (BMS-986001), an attachment inhibitor (BMS-663068) and a maturation inhibitor. Bristol-Myers Squibb is also developing a fixed-dose combination of atazanavir sulfate and Gilead’s investigational drug cobicistat.

Indication and Important Safety Information for Sustiva (efavirenz)

Indication:

Sustiva is a prescription medicine used with other antiretroviral medicines to help treat HIV-1 infection in adults and children 3 months or older who weigh at least 3.5 kg (7 lbs 12 oz).

Sustiva does not cure HIV or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections.

See your healthcare provider regularly while taking Sustiva.

Important Safety Information

What are the possible side effects of Sustiva?

•Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness.
•Dizziness, trouble sleeping or concentrating, drowsiness, and/or unusual dreams are common side effects. These side effects may be reduced if you take Sustiva (efavirenz) at bedtime on an empty stomach; they tend to go away after taking Sustiva for a few weeks. Tell your healthcare provider right away if any of these side effects continue or if they bother you. These symptoms may be more severe if Sustiva is used with alcohol and/or mood-altering (street) drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
•Rash is a common side effect that usually goes away without any change in treatment. Rash may be serious in a small number of patients. Rash occurs more commonly in children and may be a serious problem. If a rash develops, call the healthcare provider right away.
•Other common side effects include: tiredness, upset stomach, vomiting, and diarrhea. Some patients taking Sustiva have experienced increased levels of lipids (cholesterol and triglycerides) in the blood.
•Changes in body fat have been seen in some patients taking anti-HIV medicines. Increase of fat in the upper back and neck, breasts, and around the trunk may happen. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects are not known.
•Liver problems: Some patients taking Sustiva have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been reports in patients without any existing liver disease. Your healthcare provider may want to do tests to check your liver while you take Sustiva or may switch you to another medicine.
This is not a complete list of side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking Sustiva.

Who should not take Sustiva?

Do not take Sustiva if you are allergic to efavirenz, or any of the ingredients.

What should I avoid while taking Sustiva?

•Women should not become pregnant while taking Sustiva (efavirenz) and for 12 weeks after stopping it. Serious birth defects have been seen in children of women treated with Sustiva during pregnancy. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control, while on Sustiva and for 12 weeks after stopping Sustiva. Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because Sustiva (efavirenz) may make these contraceptives ineffective.
•Women with HIV should not breast-feed because they can pass HIV or may pass Sustiva through their milk to the baby. It is not known if Sustiva can be passed to your baby in your breast milk and whether Sustiva could harm your baby.
•Avoid alcohol or other medicines causing similar side effects (such as drowsiness) when taking Sustiva because they may increase those side effects.
•Do not take any other medicines without checking with your doctor.
Before using Sustiva, tell your doctor if you:

•Have problems with your liver or have hepatitis.
•Have ever had mental illness or are using drugs or alcohol.
•Have ever had seizures or take medicines for seizures. Seizures have occurred in patients taking Sustiva, usually in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you.
What important information should I know about taking other medicines with Sustiva?

Sustiva may change the effect of other medicines, including ones for HIV, and cause serious side effects. Your doctor may change your other medicines or change their doses.

MEDICINES YOU SHOULD NOT TAKE WITH Sustiva

•Do not take Sustiva with St. John’s wort (Hypericum perforatum) or products containing St. John’s wort, as it may cause decreased levels of Sustiva, increased viral load, and possible resistance to Sustiva or cross-resistance to other anti-HIV drugs.
•Do not take Sustiva if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Vascor® (bepridil), Propulsid® (cisapride), Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), or ergot medicines (for example, Wigraine® and Cafergot®).
•Sustiva should not be taken with ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), unless your doctor tells you to.
•If you are taking Sustiva (efavirenz) with REYATAZ® (atazanavir sulfate), your REYATAZ may need to be replaced if this is not the first time you are receiving treatment for your HIV infection. Other drugs that may also need to be replaced include Fortovase® (saquinavir), Invirase® (saquinavir), Biaxin® (clarithromycin), Carbatrol® (carbamazepine), Tegretol® (carbamazepine), Noxafil® (posaconazole), Sporanox® (itraconazole), and Victrelis® (boceprevir).
•Sustiva and Vfend® (voriconazole) must not be taken together at standard doses. Some doses of voriconazole can be taken at the same time as a lower dose of Sustiva, but you must check with your healthcare provider first.
Please refer to the Patient Information for a list of medicines that may require a change in the dose of either Sustiva or the other medicine.

These are not all the medicines that may cause problems if you take Sustiva. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, and herbal supplements you are taking or plan to take.

You should take Sustiva on an empty stomach, preferably at bedtime, which may make some side effects less bothersome.

Please see accompanying Full Prescribing Information, or click here.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the clinical trials of these compounds will support regulatory filings, or that the compounds will receive regulatory approvals or, if approved, that they will become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2012, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Sustiva® (efavirenz) is a registered trademark of Bristol-Myers Squibb.

Contact:
Bristol-Myers Squibb
Media:
Carrie Fernandez, 609-252-4831
carrie.fernandez@bms.com
or
Julie Ferguson, 609-252-5597
julie.ferguson@bms.com

Posted: May 2013

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