India's Cipla gets first FDA approval of oral pellet to treat HIV/AIDS in infants

India's Cipla recently got FDA approval for a pediatric formulation of the combo drug lopinavir/ritonavir to treat HIV/AIDS in the developing world, but not in the U.S., where market exclusivity rules apply.

The oral pellets can be sprinkled on sweetened porridge for administration to infants, who often have difficulty swallowing tablets and spit out bad-tasting liquid formulations. The pellets received an expedited approval under the President's Emergency Plan for AIDS Relief, which encourages the submission of previously approved antiretroviral therapies, even if the product has patent protection or market exclusivity in the U.S.

Cipla's medication is the first oral pellet to receive FDA approval under the program. It should help meet the serious clinical need to tackle HIV/AIDS among infants. In 2013, 3.2 million children were living with HIV in 2013, and 240,000 children were newly infected. Less than a quarter of children with the disease receive treatment, and half of them die before they turn two.

Cipla says it achieved the feat in drug delivery by using melt-extrusion manufacturing technology and enclosing the pellets in capsules.

The goal of the expedited approval program, developed as part of the President's Emergency Plan in 2004, is to ensure that developing countries in dire need of low-cost AIDS medications receive only products that "we would offer our own citizens," the FDA says.

Technically, the Cipla med received the FDA's "tentative approval" designation. "The 'tentative' approval signifies that the product meets all safety, efficacy, and manufacturing quality standards for marketing in the U.S., and, but for the legal market protection, it would be on the U.S. market," the FDA explains.

Lopinavir/ritonavir is marketed as Kaletra in the U.S. by AbbVie ($ABBV). It is available as a tablet or oral solution, but not as an oral pellet.

This marks the 185th drug approved under the special program. All but a few are manufactured in India, with Cipla being one of the leading beneficiaries. The company previously received tentative approval for tablet and oral formulations of lopinavir/ritonavir. Others, including Mylan ($MYL) and Aurobindo Pharma, have received tentative approvals for a tablet-based formulation of the medication.

Due to Cipla's pediatric indication, its pellets contain 40 mg of lopinavir and 10 mg of ritonavir, substantially less than the previous versions.

Cipla CEO Subhanu Saxena

"We are extremely proud to have developed this innovative formulation of LPV/r oral pellets for infants and young children," said Cipla CEO Subhanu Saxena in a statement. "Cipla has been committed to the cause of HIV/AIDS for over two decades. This innovative way of drug delivery through oral pellets for some of society's youngest AIDS sufferers reiterates our commitment to provide access to life saving medicines in the fight against HIV/AIDS."

While Cipla is the first to apply the administration method to HIV/AIDs, others are using it as well. For example, the capsule of Impax Laboratories' ($IPXL) extended-release Parkinson's med Rytary can be opened so that the beads can be sprinkled on applesauce. In addition, AstraZeneca ($AZN) recently obtained FDA approval to deliver its blood thinner Brilinta to elderly patients with difficulty swallowing. The medicine can be administered through a tube and into the nose as a crushed formulation mixed with water.

- read the release (PDF)
- here's more about the special FDA program for generic AIDS drugs