Child-friendly paediatric TB drugs will be a game changer’
A new formulation of Ethambutol 100 mg dispersible is under development
Treating young children afflicted by drug-sensitive TB
disease will no longer be the same. After years of neglect, the
availability of flavoured, easily dissolvable first-line TB drugs in
correct doses marks a watershed moment as the special needs of these
children will be met. The tablets, which are a combination of two and
more medicines in a fixed dose (FDC), are meant for children weighing
less than 25 kg.
At this momentous time, it is a
matter of pride that India has gone beyond being the “pharmacy of the
South” with the Mumbai-based Macleods Pharmaceuticals Limited supplying
the paediatric TB medicines to the entire world. “Our capacities are
sufficient to meet the global demand”, said Vijay Agarwal, Business
Development Director of Macleods Pharmaceuticals in an email to The Hindu. Lupin Pharmaceuticals, also based in Mumbai, is expected to produce the combinations later in 2016.
“The
Revised National Tuberculosis Control Program in India has
made the child TB program a priority. India expects to roll out the new
FDCs in a pilot project in 100 districts”, Dr. Cherise Scott, head of
paediatric programs at TB Alliance, Geneva said in an email to The Hindu.
According
to the World Health Organisation, at least 1 million children become
ill with TB each year and 140,000 children die each year. It’s an irony
that despite the high demand, children around the world have not had
access to appropriate TB medicines.
Young children,
who have relatively greater mass of liver in proportion to total
bodyweight, absorb and eliminate drugs faster than adults. Children are
not little adults but need higher doses of the medicines than what they
were receiving and what is prescribed for adults.
Recognizing
this, the WHO issued the dosing guidelines for children in 2010 and
recommended the composition of the fixed-dose combination in 2012.
But
pharmaceutical companies did not rise to the occasion due to several
reasons. Difficulty in diagnosing childhood TB led to underestimation of
the number of paediatric TB cases. “It’s a vicious circle, no demand,
no market, no innovation. If there is no one to support the development
and no market, no company will invest in developing such kind of drugs”,
said Dr. Philippe Duneton, Deputy Executive Director, UNITAID, Geneva
in an email to The Hindu. UNITAID and USAID provided upfront
funding and TB Alliance worked across all areas — researchers,
manufacturers, regulators, governments and advocates — to bring these
products to the market.
In the absence of medicines
of correct dosages, parents and caregivers were forced to crush or cut
medicines meant for adults to achieve correct dosing. Very often, the
crude method of crushing adult tablets resulted in imprecise dosing, not
to mention the bitter taste when tablets were broken. “It is likely
that cutting and crushing of adult pills could have contributed to drug
resistance as caregivers were never fully sure to give the right
dosages”, Dr. Malgorzata Grzemska, Coordinator, Technical Support
Coordination, Global TB programme, WHO, Geneva said in an email to The Hindu.
The
availability of child-friendly drugs of correct dosages will have many
advantages — dramatically simplify and improve adherence, improve
overall treatment, stop the growth of drug-resistant TB, and save lives.
“The FDCs will prove to be a game changer”, said Dr. Duneton.
“In
India, children are treated with many disparate regimens. Having
fixed-dose combinations in the correct doses and that are easy for
providers to give and for children to take could dramatically improve
treatment”, said Dr. Scott.
The fixed-dose drugs are
already available and countries can place an order, which can take 2-3
months for delivery. “These drugs will be primarily distributed through
WHO’s Global Drug Facility (GDF). We will supply within 10 weeks of
receipt of orders from GDF. Also, these products can be purchased [by
countries] directly from Macleods”, said Mr. Agarwal.
The
FDCs are priced at approximately $15.54 for a six-month course of
treatment. “They cost approximately 20 per cent more than today’s
improperly-dosed products,” said Dr. Scott.
Macleods
Pharmaceuticals has already submitted its applications for approval of
these products to the Drugs Controller General of India (DCGI). “We have
requested the DCGI to expedite the approval process”, said Dr. K.S.
Sachdeva, Additional Deputy Director General, Central TB Division,
Ministry of Health and Family Welfare.
Bioequivalence
studies of the new combinations have already been done, based on which
the products were approved by the WHO’s Expert Review Panel. “No other
trials need to be undertaken to start using these products”, said Mr.
Agarwal.
Children will be treated with two
fixed-dose combinations — rifampicin, isoniazid and pyrazinamide for the
first two months (intensive phase), and then isoniazid and pyrazinamide
for the remaining four months (continuation phase).
Due
to HIV infection and isoniazid resistance in the country, India
advocates four drugs, including ethambutol to treat TB. “Ethambutol has
to be given separately as it cannot be combined with other three drugs”,
said Dr. Soumya Swaminathan, Director General of ICMR.
“A
new formulation of Ethambutol 100 mg dispersible is under development.
It will be made available as soon as possible”, said Mr. Agarwal.
No comments:
Post a Comment