August 14
The Food and Drug Administration on Wednesday
approved pretomanid, an antibiotic for the highly drug-resistant
tuberculosis. (Jacquelyn Martin/AP)
The Food and Drug Administration on Wednesday approved a new drug for highly drug-resistant tuberculosis, the world’s leading infectious cause of death.
Tuberculosis kills 1.6 million people a year, about 500,000 of whom suffer from drug-resistant strains of the disease.
The
antibiotic, called pretomanid, was developed by a nonprofit group
called TB Alliance at a time when few companies are investing in the
expensive and unprofitable endeavor of creating next-generation
antibiotics.
Some researchers hope TB Alliance
can serve as a model for antibiotic drug development as health
authorities warn about the growing danger of drug-resistant infections.
The United Nations has projected such infections could cause 10 million deaths each year by 2050 if nothing is done.
“We
can have a huge impact on the lives of people who are afflicted and
also take a major step ultimately toward, really, the eradication of a
disease like TB,” said Mel Spigelman, president and chief executive of
TB Alliance. “One definite advantage of a not-for-profit is you don’t
have to look at things like returning your profits into shareholders.”
Drug companies have largely abandoned development of
antibiotics because they can cost upward of $1 billion to bring to
market but yield far less revenue than drugs for chronic conditions,
such as high blood pressure and high cholesterol, or specialty drugs
that can reap hundreds of thousands of dollars or more in revenue per
dose. Antibiotics are often inexpensive and are taken for days or weeks
at a time, whereas drugs for cancer and chronic diseases are taken for
months or years.
All antibiotics approved in the
last decade have had disappointing sales, and Achaogen, a company that
had an antibiotic approved last year, filed for bankruptcy in April.
Pretomanid
is part of a three-drug regimen against highly resistant forms of TB
and is the third FDA-approved anti-TB drug in more than 40 years. TB
Alliance said 95 of its first 107 patients in its clinical trial had a
successful outcome after six months of treatment with the three-drug
regimen. The historical treatment success rate is 34 percent.
Drug-resistant TB is treated with myriad drugs and
can require thousands of pills. It has been reported by more than 120
countries, according to the World Health Organization.
Bacterial
infections develop resistance to the antibiotics used against them,
meaning once-treatable infections, including some forms of tuberculosis,
have become extraordinarily difficult to treat. Experts have warned of a
looming post-antibiotic era, where many infections may become
untreatable.
TB Alliance said it hopes the
FDA’s approval will enable other countries, such as China, India and
South Africa, to okay the drug and to make it available to their
residents. The disease is highly contagious and spreads through
coughing, sneezing or even talking.
In the New England Journal of Medicine this month,
researchers and infectious disease physicians argued the current model
for antibiotic development is broken, especially because the few
companies that do develop them end up competing with each other to
develop drugs for the same infections. Instead, they propose nonprofit
organizations, including TB Alliance, take on a larger role because they
do not face pressure from shareholders to develop revenue-generating
drugs.
Some experts say governments need to step up and
offer more financial incentives for companies. Such efforts by the U.S.
government have led to an increase in development — 42 antibiotics were
in development in March 2019, compared with six in 2004 — but many of
the drugs have been redundant or have not addressed some of the most
urgent threats, according to the Pew Charitable Trusts.
“TB
is much more narrow and focused and has a precedent in the
not-for-profit world,” said Helen Boucher, a professor of medicine at
Tufts Medical Center and director of the Tufts Center for Integrated
Management of Antimicrobial Resistance. “Economists have told us and
others that a nonprofit model would not be adequate to meet the needs
for the robust and renewable pipeline we need in America.”
The
nonprofit model is promising for neglected diseases and those that
primarily affect residents in poorer countries, Boucher said.
“There
isn’t a market to sell [a TB drug] to make money, so it was imperative
that a nonprofit take that on,” Boucher said. “Any progress is good
progress.”
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