LONDON, May 26, 2015 /PRNewswire/ --
ViiV Healthcare, Aurobindo Pharma, and the Clinton Health Access
Initiative, Inc. (CHAI) announced today that Aurobindo Pharma has
submitted an Abbreviated New Drug Application (ANDA) for
dolutegravir 50mg, for Tentative Approval, to the Food and Drug
Administration (FDA), for the treatment of HIV. This is the first
ANDA for a generic version of dolutegravir, less than two years
after FDA approval of Tivicay® (dolutegravir) for sale in
the United States.
Upon receiving Tentative Approval from the FDA, Aurobindo Pharma
will be able to supply dolutegravir 50mg via the President's
Emergency Plan for AIDS Relief (PEPFAR) programme, following
completion of required local regulatory approval process, in the
licensed countries outside of the United
States, as per the agreement signed between Aurobindo Pharma
and ViiV Healthcare in 2014.
This submission comes less than five years after ViiV Healthcare
and CHAI signed an agreement to collaborate with the goal of
bringing innovative formulations of medicines for the treatment and
prevention of HIV/AIDS to people living with HIV in developing
countries, on an affordable yet sustainable basis.
CHAI and ViiV Healthcare worked together to identify a generic
partner after conducting feasibility research. Following this
initial joint work, ViiV Healthcare submitted necessary
documentation to the FDA providing a selective waiver letter for
the five-year period of New Chemical Entity (NCE) exclusivity that
would have otherwise prevented FDA review and Tentative Approval of
Aurobindo Pharma's ANDA at this time.
Dr. Dominique Limet, CEO, ViiV
Healthcare, said: "This first ANDA for a generic dolutegravir
confirms that our strong commitment to thinking and acting
differently to pursue new ways to expand access to our medicines,
for people living with HIV in countries where the need is most
pressing, is working."
David Ripin, PhD, Executive Vice
President, and Chief Scientific Officer, CHAI, said: "UNAIDS has
set global public health goals calling for 90 percent of those who
are HIV-positive to know their status, 90 percent of those
identified to be linked to treatment programs, and 90 percent of
those in treatment to achieve undetectable viral load. To tackle
these complex challenges, targeted efforts to facilitate access to
HIV treatment medicines, such as dolutegravir, are needed."
Mr. N. Govindarajan, Managing
Director, Aurobindo Pharma, said:
"We are pleased to be part of this innovative partnership designed
to accelerate access to medicines for treating HIV. Aurobindo
Pharma is committed to HIV care and aims to achieve the goals of
wider access to HIV treatment, care, and support; seeking to
address the spread of HIV through development of this newer class
of drugs and fixed-dose combinations for low- and middle-income
countries."
The filing by Aurobindo Pharma is the second result of the
agreement between CHAI and ViiV Healthcare and comes less than six
months after another generic manufacturer announced that it had
received Tentative Approval from the FDA for paediatric
formulations of another ViiV Healthcare antiretroviral (also under
PEPFAR for sale in licensed countries outside of the United States), through innovative
collaboration with ViiV Healthcare and CHAI.
About Clinton Health Access
Initiative
The Clinton Health Access Initiative, Inc. (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. When CHAI was
founded, many viewed this goal as unreasonable because health
systems in poor countries were too weak and prices of relevant
drugs and diagnostic tests were too high. CHAI played a leadership
role, working alongside governments and other partners, to lower
the costs of treatment and help build the in-country systems
necessary to provide lifesaving treatment to millions of people.
Since then, CHAI has pursued several similarly ambitious goals,
from scaling up pediatric AIDS treatment in order to achieve equity
with adults in a timeframe few thought possible, to rapidly
accelerating the rollout of new vaccines. CHAI has achieved many of
its most important successes when seeking to fundamentally change
the way the world approaches an issue and pushing the boundaries of
what is considered feasible in global health. For more information,
please visit: http://www.clintonhealthaccess.org
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 http://www.viivhealthcare.com.
About Aurobindo Pharma
Aurobindo Pharma Ltd. is a vertically integrated pharmaceutical
company that delivers innovative solutions. Aurobindo Pharma
leverages India's globally
competitive cost base and talented team of scientists to discover,
develop, and commercialize a range of affordable medicines for
markets across the globe. For more information, please visit
http://www.aurobindo.com.
About President's Emergency Plan for AIDS Relief
(PEPFAR)
PEPFAR is the US 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, the FDA announced a new
initiative to help ensure that those being served by the
President's 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, the FDA actively encouraged
any sponsors worldwide to submit US 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 US.
Important Information about Tivicay® (dolutegravir) in the
US
FDA Indication and Usage: TIVICAY is a human
immunodeficiency virus type 1 (HIV-1) integrase strand transfer
inhibitor (INSTI) indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection.
Use of TIVICAY in INSTI-experienced patients should be guided by
the number and type of baseline INSTI substitutions. The
efficacy of TIVICAY 50 mg twice daily is reduced in patients with
an INSTI-resistance Q148 substitution plus 2 or more additional
INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T,
G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.
Important Safety Information for Tivicay®
(dolutegravir)
Contraindication: TIVICAY is contraindicated (1) in
patients with previous hypersensitivity reaction to dolutegravir,
and (2) in patients receiving dofetilide (antiarrhythmic) due to
the potential for increased dofetilide plasma concentrations and
the risk for serious and/or life-threatening events.
Hypersensitivity Reactions: Hypersensitivity reactions
have been reported and were characterized by rash, constitutional
findings, and sometimes organ dysfunction, including liver injury.
The events were reported in 1% or fewer subjects receiving TIVICAY
in Phase 3 clinical trials. Discontinue TIVICAY and other suspect
agents immediately if signs or symptoms of hypersensitivity
reaction develop, (including but not limited to, severe rash or
rash accompanied by fever, general malaise, fatigue, muscle or
joint aches, blisters or peeling of the skin, oral blisters or
lesions, conjunctivitis, facial edema, hepatitis, eosinophilia,
angioedema, difficulty breathing.) Monitor clinical status,
including liver aminotransferases, and initiate appropriate
therapy. Delay in stopping treatment with TIVICAY or other suspect
agents after the onset of hypersensitivity may result in a
life-threatening reaction. TIVICAY is contraindicated in patients
who have experienced a hypersensitivity reaction to
dolutegravir.
Effects on Serum Liver Biochemistries in Patients with
Hepatitis B or C Coinfection: Patients with underlying
hepatitis B or C may be at increased risk for worsening or
development of transaminase elevations with use of TIVICAY. In some
cases the elevations in transaminases were consistent with immune
reconstitution syndrome or hepatitis B reactivation particularly in
the setting where anti-hepatitis therapy was withdrawn. Appropriate
laboratory testing prior to initiating therapy and monitoring for
hepatotoxicity during therapy with TIVICAY are recommended in
patients with underlying hepatic disease such as hepatitis B or C.
Fat Redistribution: Redistribution/accumulation of body
fat has been observed in patients receiving antiretroviral
therapy.
Immune Reconstitution Syndrome: During the initial phase
of treatment, immune reconstitution syndrome can occur, which may
necessitate further evaluation and treatment. Autoimmune disorders
have been reported to occur in the setting of immune
reconstitution; the time to onset is more variable and can occur
many months after initiation of treatment.
Adverse Reactions: The most commonly reported (≥2%)
adverse reactions of moderate to severe intensity in treatment
naïve adult subjects in any one trial receiving TIVICAY in a
combination regimen were insomnia (3%), fatigue (2%), and headache
(2%).
Drug Interactions: Co-administration of TIVICAY with
drugs that are strong inducers of UGT1A1 and/or CYP3A4 may result
in reduced plasma concentrations of dolutegravir and require dose
adjustments of TIVICAY.
- TIVICAY should be taken2 hours before or 6 hours after taking
cation-containing antacids or laxatives, sucralfate, oral iron
supplements, oral calcium supplements, or buffered medications.
- Consult the full Prescribing Information for TIVICAY for more
information on potentially significant drug interactions, including
clinical comments.
Pregnancy: Pregnancy category B. TIVICAY should be used
during pregnancy only if the potential benefit justifies the
potential risk. An Antiretroviral Pregnancy Registry has been
established.
Breastfeeding: Breastfeeding is NOT recommended due to
the potential for HIV transmission and the potential for adverse
reactions in nursing infants.
Paediatric Patients: Safety and efficacy of TIVICAY has
not been established in children younger than 12 years old, or
weighing <40 kg, or in INSTI-experienced paediatric patients
with documented or clinically suspected INSTI resistance.
Please visit the following link for the full US prescribing and
patient information:
https://www.viivhealthcare.com/media/58599/us_tivicay.pdf.
How Tivicay Works
Tivicay belongs to a class of HIV medicines called integrase
inhibitors. Integrase inhibitors block HIV replication by
preventing the viral DNA from integrating into the genetic material
of human immune cells (T-cells). This step is essential in the HIV
replication cycle and is also responsible for establishing chronic
infection.
Tivicay is a registered trademark of the ViiV Healthcare group
of companies.