LONDON and PITTSBURGH, Dec. 4,
2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Laboratories Limited has
received tentative approval from the U.S. Food and Drug
Administration (FDA) for its New Drug Applications (NDAs) for two
dosages of abacavir/lamivudine tablets for oral suspension for the
treatment of HIV-1 infection in paediatric patients. This is the
first version of abacavir/lamivudine with scoring to allow for dose
adjustment and is also flavoured. The FDA's tentative approval
through the President's Emergency Plan for AIDS Relief (PEPFAR)
programme means the formulations meet all of the agency's quality,
safety and efficacy standards.
The tentative approval follows a 2012 agreement between Mylan,
Clinton Health Access Initiative (CHAI) and ViiV Healthcare to
transfer the necessary technology and resources to facilitate
regulatory authority submission, production and distribution of the
new formulation, at low cost, to a total of 115 resource limited
countries including all low-middle income, least developed
countries and sub-Saharan Africa. Mylan's products are expected to
be eligible for purchase in early 2015.
The fixed dose combination of abacavir and lamivudine tablets
for oral suspension 60 mg/30 mg and 120 mg/60 mg is indicated for
the treatment of HIV-1 infection in combination with other
antiretroviral agents for paediatric patients.
More than 70% of the approximately 3.4 million children living
with HIV worldwide do not have access to appropriate care and
medicines1. Improving those numbers will require
medicines that are palatable to children and affordable to those
living in resource-limited settings.
"The approval of abacavir and lamivudine tablets for oral
suspension for marketing in developing markets demonstrates our
commitment to providing the world's 7 billion people with access to
medicine and our continued leadership in enhancing access to ARVs
to patients in developing countries," Mylan CEO Heather Bresch said. "This new, flavoured,
paediatric formulation is designed to help parents and caregivers
give accurate doses of the medication depending on the weight of
the child. The innovative work being done at Mylan, in combination
with our partnership with ViiV and CHAI, has enabled us to develop
this new product to treat children with HIV, a particularly
vulnerable population."
Dr. Dominique Limet, CEO ViiV
Healthcare commented on the news, "Based on the need clearly
identified by the Clinton Health Access Initiative in 2012, ViiV
Healthcare became the first pharmaceutical company to fully fund
the entire development process for a paediatric formulation of an
HIV medicine which would then be transferred to another company for
manufacture and distribution in the developing world. I
congratulate Mylan on this approval, made even more meaningful for
us at ViiV Healthcare as it proved that this innovative approach to
partnership can work."
David Ripin, Executive Vice
President and Chief Scientific Officer for CHAI said, "We are
pleased that our partnership with ViiV and Mylan has resulted in an
important new paediatric formulation, moving from concept to FDA
tentative approval in less than two years. The new, flavoured
dispersible medication will help meet the needs of over 500,000
children being treated for HIV in low middle income countries and
demonstrates leadership and innovation on the part of both
originators and generic suppliers together to address the needs of
paediatric patients worldwide. We are pleased to
have participated in this innovative public-private
partnership with the support of the UK Department for International
Development."
About abacavir/lamivudine
Abacavir/lamivudine
is a fixed-dose combination containing two nucleoside reverse
transcriptase inhibitors (NRTIs). NRTIs interfere with the action
of the reverse transcriptase enzyme to prevent the virus from
replicating.
Abacavir/lamivudine was approved in the US in August 2004 under the brand name Epzicom and in
Europe in December 2004 under the brand name Kivexa.
Kivexa and Epzicom are registered trademarks of the ViiV
Healthcare group of companies.
About President's Emergency Plan for AIDS Relief
(PEPFAR)
PEPFAR is the U.S. Government initiative to help
save the lives of those suffering from HIV/AIDS around the world.
This historic commitment is the largest by any nation to combat a
single disease internationally. In May
2004, in support of the President's Emergency Plan, FDA
announced a new initiative to help ensure that those being served
by the Presidents' Plan would receive safe, effective, and quality
manufactured antiretroviral drugs. This new initiative included an
expedited review process. Through guidance and an active outreach
program to the pharmaceutical industry, FDA actively encouraged any
sponsors worldwide to submit U.S. marketing applications for single
entity, fixed dose combination (FDC), and co-packaged versions of
previously approved antiretroviral therapies - even if there was
still patent or exclusivity market protection for the product in
the U.S.
Important Safety Information (ISI) for abacavir and
lamivudine tablets 60 mg/30 mg and 120 mg/60 mg for oral
suspension
Please consult the full Prescribing Information for labeled
safety information for abacavir and lamivudine tablets for oral
suspension.
BOXED WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC
ACIDOSIS AND SEVERE HEPATOMEGALY, AND EXACERBATIONS OF
HEPATITIS. See full Prescribing Information for complete
boxed warning.
- Serious and sometimes fatal hypersensitivity reactions have
been associated with abacavir-containing products.
- Hypersensitivity to abacavir is a multi-organ clinical
syndrome.
- Patients who carry the HLA‑B*5701 allele are at high risk for
experiencing a hypersensitivity reaction to abacavir.
- Discontinue abacavir and lamivudine as soon as a
hypersensitivity reaction is suspected. Regardless of HLA-B*5701
status, permanently discontinue abacavir and lamivudine if
hypersensitivity cannot be ruled out, even when other diagnoses are
possible.
- Following a hypersensitivity reaction to abacavir, NEVER
restart abacavir and lamivudine or any other abacavir‑containing
product.
- Lactic acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with the use of
nucleoside analogues.
- Severe acute exacerbations of hepatitis B have been reported in
patients who are co‑infected with Hepatitis B Virus (HBV) and Human
Immunodeficiency Virus (HIV) ‑1 and have discontinued lamivudine.
Monitor hepatic function closely in these patients and, if
appropriate, initiate anti-hepatitis B treatment.
CONTRAINDICATIONS
- Presence of HLA-B*5701 allele
- Previous hypersensitivity reaction to abacavir or any other
component of the product.
- Hepatic impairment.
WARNINGS AND PRECAUTIONS
- Hepatic decompensation, some fatal, has occurred in
HIV-1/Hepatitis C Virus (HCV) co‑infected patients receiving
combination antiretroviral therapy and interferon alfa with or
without ribavirin. Discontinue abacavir and lamivudine as medically
appropriate and consider dose reduction or discontinuation of
interferon alfa, ribavirin, or both.
- Immune reconstitution syndrome and redistribution/accumulation
of body fat have been reported in patients treated with combination
antiretroviral therapy.
- Administration of abacavir and lamivudine is not recommended in
patients receiving other products containing lamivudine- or
zidovudine-containing products or emtricitabine-containing
products.
- Pancreatitis: Use with caution in paediatric patients with a
history of pancreatitis or other significant risk factors for
pancreatitis. Discontinue treatment as clinically appropriate.
- Abacavir and lamivudine tablets 60 mg/30 mg and 120 mg/60 mg
for oral suspension contain phenylalanine as part of the artificial
sweetener, aspartame. The artificial sweetener may be harmful to
people with phenylketonuria.
ADVERSE REACTIONS
- Abacavir and lamivudine: The most commonly reported adverse
reactions of at least moderate intensity (incidence >5%) in an
adult HIV-1 clinical trial were drug hypersensitivity, insomnia,
depression/depressed mood, headache/migraine, fatigue/malaise,
dizziness/vertigo, nausea and diarrhoea.
- Abacavir: The most commonly reported adverse reactions of at
least moderate intensity (incidence >5%) in paediatric HIV-1
clinical trials were fever and/or chills, nausea and vomiting, skin
rashes and ear/nose throat infections.
- Lamivudine: The most commonly reported adverse reactions of at
least moderate intensity (incidence >15%) in paediatric patients
were fever and cough.
DRUG INTERACTIONS
- Ethanol: Decreases elimination of abacavir
- Methadone: An increased methadone dose may be required in a
small number of patients
USE IN SPECIFIC POPULATIONS
- Pregnancy: Category C abacavir and lamivudine should be used
during pregnancy only if the potential benefit justifies the
potential risk.
- Nursing mothers: Both for the potential for HIV-1 transmission
and potential for serious adverse reactions in nursing infants,
should be instructed not to breastfeed if they are receiving
abacavir and lamivudine
- Abacavir and lamivudine is not recommended in patients with
creatinine clearance less than 50 mL per min.
- Abacavir and lamivudine are contraindicated for patients with
hepatic impairment.
About Clinton Health Access Initiative
CHAI was
founded in 2002 with a transformational goal: help save the lives
of millions of people living with HIV/AIDS in the developing world
by dramatically scaling up antiretroviral treatment. Learn more
about CHAI here: www.clintonhealthaccess.org
About Mylan Laboratories
Mylan is a global
pharmaceutical company committed to setting new standards in health
care. Working together around the world to provide 7 billion people
access to high quality medicine, we innovate to satisfy unmet
needs; make reliability and service excellence a habit; do what's
right, not what's easy; and impact the future through passionate
global leadership. We offer a growing portfolio of more than 1,300
generic pharmaceuticals and several brand medications. In addition,
we offer a wide range of antiretroviral therapies, upon which
approximately 40% of HIV/AIDS patients in developing countries
depend. We also operate one of the largest active pharmaceutical
ingredient manufacturers and currently market products in
approximately 140 countries and territories. Our workforce of more
than 20,000 people is dedicated to improving the customer
experience and increasing pharmaceutical access to consumers around
the world. Learn more at mylan.com.
About ViiV Healthcare
ViiV Healthcare is a global
specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and
Pfizer (NYSE: PFE) dedicated to delivering advances in treatment
and care for people living with HIV. Shionogi joined as a
shareholder in October 2012. The
company's aim is to take a deeper and broader interest in HIV/AIDS
than any company has done before and take a new approach to deliver
effective and new HIV medicines, as well as support communities
affected by HIV. For more information on the company, its
management, portfolio, pipeline, and commitment, please
visit www.viivhealthcare.com.
References:
1. WHO, UNAIDS and UNICEF, Global HIV/AIDS
response: epidemic update and health sector progress towards
universal access: progress report 2011, Geneva, 2011.
Mylan cautionary statement regarding forward-looking
statements: This press release includes statements that
constitute "forward-looking statements," including with regard to
Mylan's product approvals, sales of products and strategy, future
growth and performance. These statements are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. Because such statements inherently involve risks and
uncertainties, actual future results may differ materially from
those expressed or implied by such forward-looking statements.
Factors that could cause or contribute to such differences include,
but are not limited to: risks inherent in legal and regulatory
processes; the impacts of competition; changes in economic and
financial conditions of Mylan's business; strategies by competitors
or other third parties to delay or prevent product introductions;
uncertainties and matters beyond the control of management; and the
other risks detailed in Mylan's filings with the Securities and
Exchange Commission. Mylan undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
GlaxoSmithKline cautionary statement regarding
forward-looking statements: GSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect GSK's operations are
described under Item 3.D "Risk factors" in the company's Annual
Report on Form 20-F for 2013.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-receives-tentative-fda-approval-for-paediatric-formulations-of-abacavirlamivudine-through-innovative-collaboration-with-viiv-healthcare-and-clinton-health-access-initiative-300005004.html
SOURCE ViiV Healthcare