Resumen: Un comité asesor de la FDA recomienda la rápida aprovación del antibiótico TOBI (Tobramicina para inhalación). Se espera que la FDA de su aprovación en un plazo de seis meses en vez del año que suelen durar estos trámites. Los estudios realizados han demostrado buenos resultados, aunque se han observado en algunos pacientes problemas auditivos después de su utilización.
BETHESDA, Md.(Reuters) - A Food and Drug Administration advisory panel recommended rapid approval Friday of a new way to get antibiotics into the lungs of cystic fibrosis patients.
Seattle-based Pathogenesis Corp.says its TOBI, or tobramycin for inhalation, is better than intravenous doses of drugs at fighting the most deadly bacterial infection that affects those suffering from cystic fibrosis.
The panel voted unanimously to approve the new delivery system, which is meant to replace a cumbersome infusion of the antibiotic.
``Clearly TOBI will become a major weapon in our fight to stop the progression of this destructive lung disease,'' Bob Beall of the Cystic Fibrosis foundation said.
``Any new therapy that can improve lung function or ameliorate the decline would be an important new advance for our patients,'' Michael Bowman of the Los Angles Children's Hospital, who worked on the trials for the company, told the panel.
The FDA, which usually follows its panels' advice, has granted the drug an expedited review and is expected to decide whether to approve it within six months, instead of the usual one year.
There were some concerns about safety. Eight of the patients using TOBI had tinnitus, a ringing of the ears that could point to hearing loss -- a possible side-effect of these antibiotics.
``I don't have any problem with the efficacy and safety and think there's a need to have it approved,'' panelist Nancy Henry of the Mayo Clinic in Minnesota said before the vote.
Other panelists expressed concern about resistance. They were confused by data that showed more bacteria in the bodies of the volunteers after they took the drug, compared with volunteers on placebo -- although there was no immediate evidence that the bacteria were developing resistance to the drug.
Nonetheless, TOBI had fewer side-effects than intravenous delivery of the drug.
Tobramycin is formulated to fight Pseudomonas aeruginosa, which causes eight times the number of deaths and twice the number of hospitalizations compared with other bacterial infections in cystic fibrosis patients.
TOBI uses a nebulizer, which makes the medicine into an aerosol -- a far more effective way to get the medicine into the lungs. Injections of antibiotics often involve very high, and sometimes toxic, doses because the drug circulates in the entire body.
In Phase III trials involving 468 patients in 69 cystic fibrosis care centers, the company said TOBI significantly improved lung function, measured by the amount of breath patients could expel in one second, compared with patients using a dummy aerosol. The increase was greater than that seen with any other drug.
Patients using TOBI had 26 percent fewer hospitalizations and spent one-third fewer days in a hospital than those taking the placebo. The number of bacteria in the phlegm of patients taking TOBI declined.
FDA officials said they thought there was statistical significance in the efficacy measures of one of the Phase III trials of the drug but not the other.
The panel asked for post-marketing studies and careful monitoring of the drug's effects -- especially regarding the hearing loss.
TOBI is designed to be taken taken with other antibiotics and drugs.
Cystic fibrosis affects about 30,000 Americans, mostly of European descent, and another 25,000 people in Europe. It is caused by a genetic defect that causes cells to produce thick, sticky mucus that clogs the lungs and intestines and can make them susceptible to infection.
Reut16:05 11-21-97
(21 Nov 1997 16:04 EST)
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