ImClone, BSM to resubmit application to expand use of Erbitux
NEW YORK Eli Lilly & Co. subsidiary ImClone Systems and Bristol-Myers Squibb announced last week that they will withdraw and resubmit an application to expand the use of Erbitux (cetuximab), a monoclonal antibody for treating cancer, to treatment of non-small cell lung cancer.
The two companies announced the decision Friday after discussion with the Food and Drug Administration, based on a chemistry manufacturing and controls issue concerning the pre-clinical comparability of the version of Erbitux marketed in the United States and the version marketed outside the United States by Merck KGaA.
The discussions with the FDA do not affect Erbitux as BMS and ImClone currently market it.
Drug non-compliance rates rise as economic toll worsens in U.S.
WASHINGTON A healthcare research group reports that the proportion of children and working-age Americans who went without a prescription drug because of cost concerns jumped to one in seven in 2007.
That marks a significant rise in non-compliance rates from 2003, when the ratio of American children and workers who said they were deterred by cost concerns from taking one or more medicines was one in 10.
“Rising prescription drug costs and less generous drug coverage likely contributed to the growth in non-elderly Americans who went without a prescribed medication because of cost concerns — from 10.3% in 2003 to 13.9% in 2007,” noted the Center for Studying Health System Change [HSC] in a report released Jan. 22. The report is based on findings from HSC’s 2007 Health Tracking Household Survey, a nationally representative survey containing information on 10,400 working-age adults (ages 19-64) and 2,600 children.
The most vulnerable groups — those with low incomes, chronic conditions and the uninsured — continue to face the greatest unmet prescription drug needs, the study found. Uninsured, working-age Americans saw the biggest jump in unmet prescription drug needs between 2003 and 2007, with the proportion rising from 26 percent to almost 35%, researchers noted.
Even patients covered by Medicaid are falling off the prescription coverage screen, according to the report. Nearly one in four working-age adults with Medicaid or other state insurance reported difficulties affording prescription drugs, while nearly three in 10 working-age Medicare beneficiaries reported such problems.
“At the same time, a growing proportion [10.7%] of working-age Americans with employer-sponsored insurance reported going without prescription medications in 2007, up from with 8.7% in 2003,” HSC reported.
“The number of Americans who cannot afford prescription medications is likely to grow as the economy continues to decline and the ranks of the uninsured grow,” said Laurie Felland, an HSC senior health researcher and coauthor of the study with HSC senior health researcher Jim Reschovsky. HSC is a nonpartisan health policy research organization funded in part by the Robert Wood Johnson Foundation, which funded the survey and the study.
The study’s findings are detailed in a new HSC tracking report — titled More Nonelderly Americans Face Problems Affording Prescription Drug. Among its other findings:
· More than 36 million people aged 19 to 64 and children went without prescription drugs because of cost concerns in 2007, an increase of 11.7 million people from 2003.
· Unmet prescription drug needs among working-age adults increased from 13.8% to 17.8% between 2003 and 2007 — a 29% increase. “Because children typically are in better health and require fewer medications than adults, they have fewer prescription drug access problems,” researchers noted. “Nevertheless, unmet prescription drug needs between 2003 and 2007 grew even faster among children, from 3.1% to 5% — affecting 3.9 million children in 2007.”
· More than one in four working-age adults with a chronic condition reported unmet prescription drug needs in 2007, compared with 12.9 percent of people without a chronic condition.
· Uninsured working-age adults with one or more chronic conditions had the worst access across groups, with almost two-thirds reporting unmet prescription drug needs.
· Low-income families with income less than 200 percent of the federal poverty level, or $41,300 for a family of four in 2007, reported greater difficulty affording prescription drugs than higher-income people. In 2007, almost three in 10 low-income, working-age adults reported prescription drug access problems, compared with 13.5% of higher-income, working-age adults.
· More than four in 10 low-income people with chronic conditions reported unmet prescription drug needs in 2007, compared with 8.9% of higher-income people without chronic conditions.
New drug for plaque psoriasis approved by FDA
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating plaque psoriasis, agency records show.
The FDA announced Monday that it had approved Galderma Labs’ Vectical Ointment (calcitriol).
A number of companies already market injectable and oral formulations of calcitriol, according to the FDA?s Orange Book, though none market topical ointments.