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FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

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doravirine

Treatment for HIV Infection

FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

KENILWORTH, N.J.–(BUSINESS WIRE)– January 8, 2018 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. The NDAs include data for doravirine (DOR) as a once-daily tablet for use in combination with other antiretroviral agents, and for use of doravirine with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a once-daily fixed-dose combination single tablet as a complete regimen (DOR/3TC/TDF). The FDA has set a target action date of Oct. 23, 2018, for both applications under the Prescription Drug User Fee Act (PDUFA).

“Since the earliest days of the epidemic, Merck has sustained our commitment to research and meeting the needs of people living with HIV. Doravirine was engineered by our research team to provide a meaningful new treatment approach and address unmet medical needs in the treatment of HIV-1 infection,” said Dr. George Hanna, associate vice president, global clinical development, Merck Research Laboratories. “We have been pleased with the clinical findings to date and look forward to working with the FDA as it reviews our applications.”

The NDAs are based upon the findings at Week 48 of two ongoing Phase 3 trials, DRIVE-FORWARD and DRIVE-AHEAD, evaluating the efficacy and safety of doravirine and the fixed-dose combination regimen of DOR/3TC/TDF, respectively. These data were previously presented at CROI-2017 and IAS 2017, respectively.

About Doravirine

Doravirine (MK-1439, DOR) is an investigational NNRTI being evaluated by Merck for the treatment of HIV-1 infection. DOR is being evaluated in several ongoing clinical trials both as a once-daily single-entity tablet in combination with other antiretroviral agents in a tailored regimen, and as a once-daily fixed-dose combination (DOR/3TC/TDF) in a complete single tablet regimen. Phase 3 trials include DRIVE-FORWARD, a trial comparing DOR to once-daily ritonavir-boosted darunavir (DRV+r), each administered in combination with FTC/TDF or abacavir (ABC)/3TC, in treatment-naïve adults; DRIVE-AHEAD, a trial comparing DOR/3TC/TDF to EFV/FTC/TDF in treatment-naïve adults; and DRIVE-SHIFT, a trial evaluating a switch to DOR/3TC/TDF in HIV-1 infected adults who are currently virologically suppressed on another antiretroviral regimen. Other ongoing Phase 2 clinical trials include an evaluation of DOR/3TC/TDF in treatment-naïve adults with transmitted resistance to NNRTIs and in individuals switching from EFV due to intolerability.

About DRIVE-FORWARD

DRIVE-FORWARD is a multicenter, double-blind, randomized non-inferiority trial in which 769 treatment-naïve adults with HIV-1 infection received either DOR (100 mg) or DRV+r (800 mg +100 mg), both administered orally once-daily in combination with either TDF/FTC or ABC/3TC. The primary endpoint of the clinical trial was the proportion of participants with HIV-1 RNA less than 50 copies/mL at Week 48. Secondary endpoints included an evaluation of the effects of DOR and DRV+r on fasting serum lipids, change from baseline in CD4+ T-cell count, and evaluation of safety and tolerability. The trial consists of a 96-week double-blind treatment period (base study) and an open label extension after participants complete the base study. For further information regarding DRIVE-FORWARD please visit www.clinicaltrials.gov clinical trial registry number NCT02275780.

About DRIVE-AHEAD

DRIVE-AHEAD is an ongoing Phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial evaluating the safety and efficacy of a once-daily, single-tablet, fixed-dose combination consisting of DOR/3TC/TDF (100mg/300mg/300mg) versus a once daily, single-tablet, fixed-dose combination of EFV/FTC/TDF (600mg/200mg/300mg) in treatment-naïve HIV-1 infected adults. The primary endpoint of the clinical trial was the proportion of participants with HIV-1 RNA less than 50 copies/mL at Week 48. The primary safety endpoint was the proportion of participants with neuropsychiatric adverse events through Week 48 in the following pre-specified categories: dizziness, sleep disorders and disturbances, and the inability to think clearly or concentrate. Secondary endpoints included an evaluation of the effects of DOR/3TC/TDF and EFV/FTC/TDF on fasting serum lipids, change from baseline in CD4+ T-cell count, and evaluation of safety and tolerability. The trial consists of a 96-week double-blind treatment period (base study) and an open label extension after participants complete the base study. For further information regarding DRIVE-AHEAD please visit www.clinicaltrials.gov clinical trial registry number NCT02403674.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies 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 health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. 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; the company’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 the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company 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 the company’s 2016 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)

Source: Merck

Posted: January 2018

doravirine FDA Approval History

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